Clearview Im
FDA 510(k) K981946 · Unipath , Ltd.
510(k) numberK981946
Submission
- Device name
- Clearview Im
- Applicant
- Unipath , Ltd.
Bedford, GB - Received
- June 3, 1998
- Decision date
- December 10, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KTN – System, Test, Infectious Mononucleosis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5640
- Specialty
- Immunology
Other 510(k)s with product code KTN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K181436 | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II…KTN · Special | SEKISUI Diagnostics, LLC | 06/22/2018SE |
| K042272 | Acon Mononucleosis Rapid Test Strip (Whole Blood/Serum/Plasma)KTN · Traditional | ACON Laboratories, Inc. | 02/28/2005SE |
| K030215 | Biorapid MononucleosisKTN · Traditional | Instrumentation Laboratory CO | 02/24/2003SE |
| K012901 | Color-MonogenKTN · Traditional | Instrumentation Laboratory CO | 09/27/2001SE |
| K982634 | Dryspot Infectious Mononucleosis KitKTN · Traditional | Oxoid , Ltd. | 01/28/1999SE |
| K972457 | Monocol/Lex-Im TestKTN · Traditional | Immunostics Inc., | 12/01/1997SE |
| K972231 | Osom Mono Test 143KTN · Traditional | Wyntek Diagnostics, Inc. | 08/26/1997SE |
| K963425 | Genzyme Diagnostics Contrast MonoKTN · Traditional | Genzyme Diagnostics | 02/25/1997SE |
| K961024 | Biosign Mono-Plus Wb,Biosign Mono Wb,Mono-Plus Wb,Accusign Mono WBKTN · Traditional | Princeton BioMeditech Corp. | 02/04/1997SE |
| K961550 | Qualitrol Mono Control Serum SetKTN · Traditional | Consolidated Technologies, Inc. | 09/24/1996SE |
More from Consolidated Technologies, Inc.
| 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 |
Questions and answers
When was Clearview Im cleared by the FDA?
Clearview Im (K981946) received a 510(k) decision of Substantially Equivalent on December 10, 1998, 190 days after the submission was received.
What is the product code of K981946?
The FDA product code is KTN – System, Test, Infectious Mononucleosis, a Class II (moderate risk) device regulated under 21 CFR 866.5640.