Pb Diagnostic Systems, Inc.
Medical device manufacturer in Westwood, MA.
35510(k) clearances
0PMA approvals
0recalls
Device types
- KHO Fluorometer, For Clinical Use 2
- JHI Visual, Pregnancy Hcg, Prescription Use 2
- CEC Radioimmunoassay, Free Thyroxine 1
- KLS Enzyme Immunoassay, Theophylline 1
- JJQ Colorimeter, Photometer, Spectrophotometer… 1
- CFT Radioimmunoassay, Prolactin (Lactogen) 1
- LGD Enzyme Linked Immunoabsorbent Assay… 1
- LCR Fluorescent Immunoassay, Tobramycin 1
- LIN Antisera, Conjugated Fluorescent… 1
- CGJ Radioimmunoassay, Follicle-Stimulating… 1
- LCQ Fluorescent Immunoassay Gentamicin 1
- CDP Radioimmunoassay, Total Triiodothyronine 1
- KHQ Radioassay, Triiodothyronine Uptake 1
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 1
- KXT Enzyme Immunoassay, Digoxin 1
- LEG Enzyme Immunoassay, Valproic Acid 1
- LET Fluorescent Immunoassay, Phenobarbital 1
- KLI Enzyme Immunoassay, Non-Radiolabeled, Total… 1
- DLZ Enzyme Immunoassay, Phenobarbital 1
- LGR Fluorescence Polarization Immunoassay… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K940507 | Opus FT4 Test SystemCEC · Traditional | 07/28/1994SE |
| K934762 | Opus Procainamide Test SystemLAR · Traditional | 07/20/1994SE |
| K933389 | Opus Cmv-GLFZ · Traditional | 06/28/1994SE |
| K934137 | Opus(R) Serology Controls, ModificationMJX · Traditional | 03/07/1994SE |
| K935229 | Opus DigitoxinDPG · Traditional | 12/22/1993SE |
| K934705 | Opus NapaLAN · Traditional | 11/22/1993SE |
| K933675 | Opus Total CKCGS · Traditional | 09/08/1993SE |
| K933066 | Opus EstradiolCHP · Traditional | 09/08/1993SE |
| K932279 | Opus(R) Total B-Hcg Test SystemJHI · Traditional | 07/08/1993SE |
| K926131 | Opus Magnum AnalyzerKHO · Traditional | 06/07/1993SE |
| K924957 | Opus(R) VancomycinLEH · Traditional | 12/11/1992SE |
| K924429 | Opus(R) Ck-MbJHY · Traditional | 10/15/1992SE |
| K915838 | Opus Ferritin Test SystemDGE · Traditional | 03/18/1992SE |
| K915850 | Opus Myoglobin Test SystemDDR · Traditional | 03/17/1992SE |
| K913938 | Opus(R) LH Test SystemCEP · Traditional | 11/07/1991SE |
| K913295 | Opus(R) Plus AnalyzerJJQ · Traditional | 09/11/1991SE |
| K913280 | Opus(R) Prolactin Test SystemCFT · Traditional | 08/16/1991SE |
| K911834 | Opus(R) RozoLGD · Traditional | 08/12/1991SE |
| K911940 | Opus(R) TobramycinLCR · Traditional | 07/01/1991SE |
| K905257 | Opus CMV Test SystemLIN · Traditional | 04/17/1991SE |
| K911409 | Opus FSHCGJ · Traditional | 04/16/1991SE |
| K905721 | Opus GentamicinLCQ · Traditional | 02/21/1991SE |
| K905410 | Opus T3 Test SystemCDP · Traditional | 02/04/1991SE |
| K902797 | Opus TM T-Uptake Test SystemKHQ · Traditional | 07/30/1990SE |
| K902333 | Opus TSH Test SystemJLW · Traditional | 07/05/1990SE |
| K901935 | Opus (TM) HCGJHI · Traditional | 06/26/1990SE |
| K901547 | Opus(Tm) Digoxin Test SystemKXT · Traditional | 06/26/1990SE |
| K901538 | Modified Opus Valproic Acid Test SystemLEG · Traditional | 06/26/1990SE |
| K901537 | Modified Opus Phenobarbital Test SystemLET · Traditional | 06/12/1990SE |
| K897193 | Opus T4 Test SystemKLI · Traditional | 03/19/1990SE |
| K896861 | Opus Phenobarbital Test SystemDLZ · Traditional | 01/11/1990SE |
| K896868 | Opus Phenytoin Test SystemLGR · Traditional | 01/02/1990SE |
| K896860 | Opus Carbamazepine Test SystemKLT · Traditional | 01/02/1990SE |
| K894159 | Opus Immunoassay SystemKHO · Traditional | 08/03/1989SE |
| K885044 | Behring Polaroid Opus TheophyllineKLS · Traditional | 12/29/1988SE |