Unipath , Ltd.
Medical device manufacturer in Bedford, GB.
73510(k) clearances
0PMA approvals
0recalls
Device types
- LCX Kit, Test, Pregnancy, Hcg, Over The Counter 20
- JTN Susceptibility Test Discs, Antimicrobial 10
- JHI Visual, Pregnancy Hcg, Prescription Use 5
- CEP Radioimmunoassay, Luteinizing Hormone 4
- GKZ Counter, Differential Cell 2
- GTZ Antisera, All Groups, Streptococcus Spp. 2
- JJX Single (Specified) Analyte Controls… 2
- KTN System, Test, Infectious Mononucleosis 2
- NGE Test, Luteinizing Hormone (Lh), Over The… 2
- MSJ Apolipoproteins 2
- DCF Albumin, Antigen, Antiserum, Control 2
- DEW Igg, Antigen, Antiserum, Control 1
- DAD Haptoglobin, Antigen, Antiserum, Control 1
- LKL Alpha-1-Acid-Glycoprotein, Antigen… 1
- CZP Iga, Antigen, Antiserum, Control 1
- GTY Antigens, All Groups, Streptococcus Spp. 1
- LER Fluorescent Immunoassay, Theophylline 1
- JBQ Antithrombin Iii Quantitation 1
- DCK C-Reactive Protein, Antigen, Antiserum, And… 1
- DHR System, Test, Rheumatoid Factor 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K061769 | E.P.T. Certainty 1-STEP Pregnancy TestLCX · Special | 07/03/2006SE |
| K060128 | Clearblue Easy Digital Pregnancy TestLCX · Traditional | 05/25/2006SE |
| K051638 | Inverness Medical Testpack + Plus Strep a with ObcGTY · Traditional | 12/06/2005SE |
| K050930 | E.P.T. Certainty Pregnancy TestLCX · Special | 05/12/2005SE |
| K042280 | Fact Plus One-Step Pregnancy Test KitLCX · Special | 09/10/2004SE |
| K041404 | Clearblue Easy Easy Read Pregnancy TestLCX · Special | 06/08/2004SE |
| K040341 | Clearblue Easy Earliest Results Pregnancy TestLCX · Special | 03/08/2004SE |
| K040329 | Modification to E.P.T. Pregnancy TestLCX · Special | 03/08/2004SE |
| K033658 | E.P.T. Pregnancy TestLCX · Special | 01/16/2004SE |
| K032939 | Ept Certainty Pregnancy TestLCX · Special | 10/20/2003SE |
| K030659 | Clearblue Easy Digital Pregnancy TestLCX · Traditional | 05/02/2003SE |
| K023699 | Clearblue Easy Early Result Pregnancy TestLCX · Special | 11/27/2002SE |
| K013874 | Clearplane Easy Ovulation TestCEP · Traditional | 02/19/2002SE |
| K013372 | Clearblue Easy Early Result Pregnancy TestLCX · Special | 11/09/2001SE |
| K993333 | Clearplan Easy II Home Pregnancy TestLCX · Traditional | 12/16/1999SE |
| K993703 | Clearview Easy HCG Pregnancy TestJHI · Traditional | 12/02/1999SE |
| K990262 | Clearplan Easy Home Pregnancy TestLCX · Traditional | 04/07/1999SE |
| K990223 | Modification of Clearplan Easy Fertility MonitorNGE · Special | 02/24/1999SE |
| K981946 | Clearview ImKTN · Traditional | 12/10/1998SE |
| K981207 | Clearplan Easy Fertility MonitorNGE · Traditional | 10/28/1998SE |
| K981271 | Clearplan Easy Ovulation TestCEP · Traditional | 06/25/1998SE |
| K964495 | Cefepine Antimicrobial Susceptibility Test DiscJTN · Traditional | 02/07/1997SE |
| K964492 | Ciprofloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | 02/07/1997SE |
| K964491 | Norfloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | 02/07/1997SE |
| K964490 | Aztreonam Antimicrobial Susceptibility Test DiscJTN · Traditional | 02/07/1997SE |
| K964489 | Cefaclor Antimicrobial Susceptibility Test DiscJTN · Traditional | 02/07/1997SE |
| K964487 | Imipenem Antimicrobial Susceptibility Test DiscJTN · Traditional | 02/07/1997SE |
| K964512 | Ceftizoxime Antimicrobial Susceptibility Test DiscJTN · Traditional | 02/06/1997SE |
| K964501 | Sulbactam/Ampicillin Antimicrobial Susceptibility Test DiscJTN · Traditional | 02/06/1997SE |
| K964496 | Cefixime Antimicrobial Susceptibilty Test DiscJTN · Traditional | 02/06/1997SE |
| K964493 | Ofloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | 02/06/1997SE |
| K962296 | Streptolex-StatGTZ · Traditional | 12/16/1996SE |
| K955067 | Clearview C. Diff aMCB · Traditional | 09/13/1996SE |
| K960316 | Clearblue EasyLCX · Traditional | 04/29/1996SE |
| K940557 | Staphytect-OdLHJ · Traditional | 07/28/1994SE |
| K934923 | Clearview Positive and Negative Urine HCG Contol SetJJX · Traditional | 12/29/1993SE |
| K934922 | Clearview Positive and Negative HCG Urine Control SetJJX · Traditional | 12/29/1993SE |
| K924673 | Clearview HCGJHI · Traditional | 05/11/1993SE |
| K913305 | Cell-Dyn 3000A Multi-Parameter Auto Hema AnalzyerGKZ · Traditional | 11/22/1991SE |
| K914240 | Clearview HCG Serum/Urine Profess Preg Test, ModifJHI · Traditional | 10/25/1991SE |
| K905741 | Clearview HCG Serum/UrineJHI · Traditional | 05/15/1991SE |
| K911566 | Clearblue EasyLCX · Traditional | 05/06/1991SE |
| K910946 | Clearview HCGJHJ · Traditional | 04/01/1991SE |
| K905742 | Clearblue EasyLCX · Traditional | 02/13/1991SE |
| K903665 | Cell-Dyn 1400 Multi-Parameter Automated HematologyGKZ · Traditional | 10/04/1990SE |
| K902892 | Cell-Dyn CalibratorKRZ · Traditional | 09/10/1990SE |
| K902391 | Cell-Dyn 3000 ControlJCN · Traditional | 08/22/1990SE |
| K895280 | Clearview ChlamydiaLJC · Traditional | 01/29/1990SE |
| K894579 | Clearplan EasyCEP · Traditional | 10/12/1989SE |
| K893422 | Clearview Strep aGTZ · Traditional | 06/23/1989SE |
| K890675 | The Turbox Analyser System Complement C3 and C4CZW · Traditional | 03/06/1989SE |
| K884180 | Turbox Rheumatoid Factor Immunological Test SystemDHR · Traditional | 02/03/1989SE |
| K884179 | Turbox FibrinogenKQJ · Traditional | 12/20/1988SE |
| K884144 | Turbox Antithrombin IIIJBQ · Traditional | 12/20/1988SE |
| K882570 | Turbox Theophylline AssayLER · Traditional | 11/10/1988SE |
| K883540 | Oxoid Infectious Mononucleosis KitKTN · Traditional | 10/19/1988SE |
| K883777 | Clearview HCGJHI · Traditional | 10/06/1988SE |
| K882416 | Clearblue EasyLCX · Traditional | 07/28/1988SE |
| K873868 | ALPHA-1-ACID Glycoprotein (Orosomucoid)LKL · Traditional | 10/20/1987SE |
| K873866 | HaptoglobinDAD · Traditional | 10/20/1987SE |
| K873862 | Albumin in SerumDCF · Traditional | 10/20/1987SE |
| K873871 | Immunoglobulins MDFT · Traditional | 10/13/1987SE |
| K873870 | Immunoglobulins GDEW · Traditional | 10/13/1987SE |
| K873869 | Immunoglobulins aCZP · Traditional | 10/13/1987SE |
| K873867 | TransferrinDDG · Traditional | 10/13/1987SE |
| K873865 | CRPDCK · Traditional | 10/13/1987SE |
| K873864 | Apolipoprotein BMSJ · Traditional | 10/13/1987SE |
| K873863 | Apolipoprotein A1MSJ · Traditional | 10/13/1987SE |
| K873861 | Albumin in UrineDCF · Traditional | 10/13/1987SE |
| K873401 | TurboxJZW · Traditional | 09/23/1987SE |
| K871332 | ClearplanCEP · Traditional | 08/05/1987SE |
| K864373 | Clearblue Pregnancy Testing Kit (Modification)LCX · Traditional | 01/09/1987SE |
| K861168 | Clearblue Pregnancy Testing KitLCX · Traditional | 04/24/1986SE |