Pb Diagnostic Systems, Inc.
Westwood, MA, US
Pb Diagnostic Systems, Inc. appears in FDA device records in Westwood, MA. FDA records list 35 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 35
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 35 510(k) clearances for Pb Diagnostic Systems, Inc. between 1988 and 1994. The busiest year on record is 1990, with 10. The most recent is 1994, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 10 |
| 1991 | 9 |
| 1992 | 4 |
| 1993 | 6 |
| 1994 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K940507 | OPUS FT4 TEST SYSTEM | CEC | Substantially Equivalent | |
| K934762 | OPUS PROCAINAMIDE TEST SYSTEM | LAR | Substantially Equivalent | |
| K933389 | OPUS CMV-G | LFZ | Substantially Equivalent | |
| K934137 | OPUS(R) SEROLOGY CONTROLS, MODIFICATION | MJX | Substantially Equivalent | |
| K935229 | OPUS DIGITOXIN | DPG | Substantially Equivalent | |
| K934705 | OPUS NAPA | LAN | Substantially Equivalent | |
| K933675 | OPUS TOTAL CK | CGS | Substantially Equivalent | |
| K933066 | OPUS ESTRADIOL | CHP | Substantially Equivalent | |
| K932279 | OPUS(R) TOTAL B-HCG TEST SYSTEM | JHI | Substantially Equivalent | |
| K926131 | OPUS MAGNUM ANALYZER | KHO | Substantially Equivalent | |
| K924957 | OPUS(R) VANCOMYCIN | LEH | Substantially Equivalent | |
| K924429 | OPUS(R) CK-MB | JHY | Substantially Equivalent | |
| K915838 | OPUS FERRITIN TEST SYSTEM | DGE | Substantially Equivalent | |
| K915850 | OPUS MYOGLOBIN TEST SYSTEM | DDR | Substantially Equivalent | |
| K913938 | OPUS(R) LH TEST SYSTEM | CEP | Substantially Equivalent | |
| K913295 | OPUS(R) PLUS ANALYZER | JJQ | Substantially Equivalent | |
| K913280 | OPUS(R) PROLACTIN TEST SYSTEM | CFT | Substantially Equivalent | |
| K911834 | OPUS(R) ROZO | LGD | Substantially Equivalent | |
| K911940 | OPUS(R) TOBRAMYCIN | LCR | Substantially Equivalent | |
| K905257 | OPUS CMV TEST SYSTEM | LIN | Substantially Equivalent | |
| K911409 | OPUS FSH | CGJ | Substantially Equivalent | |
| K905721 | OPUS GENTAMICIN | LCQ | Substantially Equivalent | |
| K905410 | OPUS T3 TEST SYSTEM | CDP | Substantially Equivalent | |
| K902797 | OPUS TM T-UPTAKE TEST SYSTEM | KHQ | Substantially Equivalent | |
| K902333 | OPUS TSH TEST SYSTEM | JLW | Substantially Equivalent | |
| K901935 | OPUS (TM) HCG | JHI | Substantially Equivalent | |
| K901547 | OPUS(TM) DIGOXIN TEST SYSTEM | KXT | Substantially Equivalent | |
| K901538 | MODIFIED OPUS VALPROIC ACID TEST SYSTEM | LEG | Substantially Equivalent | |
| K901537 | MODIFIED OPUS PHENOBARBITAL TEST SYSTEM | LET | Substantially Equivalent | |
| K897193 | OPUS T4 TEST SYSTEM | KLI | Substantially Equivalent | |
| K896861 | OPUS PHENOBARBITAL TEST SYSTEM | DLZ | Substantially Equivalent | |
| K896868 | OPUS PHENYTOIN TEST SYSTEM | LGR | Substantially Equivalent | |
| K896860 | OPUS CARBAMAZEPINE TEST SYSTEM | KLT | Substantially Equivalent | |
| K894159 | OPUS IMMUNOASSAY SYSTEM | KHO | Substantially Equivalent | |
| K885044 | BEHRING POLAROID OPUS THEOPHYLLINE | KLS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LINAntisera, Conjugated Fluorescent, Cytomegalovirus
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JHYColorimetric Method, Cpk Or Isoenzymes
- KLTEnzyme Immunoassay, Carbamazepine
- KXTEnzyme Immunoassay, Digoxin
- LANEnzyme Immunoassay, N-Acetylprocainamide
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DLZEnzyme Immunoassay, Phenobarbital
- LAREnzyme Immunoassay, Procainamide
- KLSEnzyme Immunoassay, Theophylline
- LEGEnzyme Immunoassay, Valproic Acid
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LGRFluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
- LCQFluorescent Immunoassay Gentamicin
- LETFluorescent Immunoassay, Phenobarbital
- LCRFluorescent Immunoassay, Tobramycin
- KHOFluorometer, For Clinical Use
- DGEIgd, Rhodamine, Antigen, Antiserum, Control
- MJXKit, Serological, Positive Control
- DDRMyoglobin, Antigen, Antiserum, Control
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- KHQRadioassay, Triiodothyronine Uptake
- DPGRadioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.
- CHPRadioimmunoassay, Estradiol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CEPRadioimmunoassay, Luteinizing Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDPRadioimmunoassay, Total Triiodothyronine
- LEHRadioimmunoassay, Vancomycin
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain