Company ยท US
Pb Diagnostic Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1994. Name variants (Inc, Corp, punctuation) are merged.
35510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 |
| KHO | Fluorometer, For Clinical Use | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 |
| DGE | Igd, Rhodamine, Antigen, Antiserum, Control | 1 |
| DLZ | Enzyme Immunoassay, Phenobarbital | 1 |
| DPG | Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep. | 1 |
| JHY | Colorimetric Method, Cpk Or Isoenzymes | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 |
| KLS | Enzyme Immunoassay, Theophylline | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 28, 1994 | K940507 | OPUS FT4 TEST SYSTEM Pb Diagnostic Systems, Inc. | CEC |
| Jul 20, 1994 | K934762 | OPUS PROCAINAMIDE TEST SYSTEM Pb Diagnostic Systems, Inc. | LAR |
| Jun 28, 1994 | K933389 | OPUS CMV-G Pb Diagnostic Systems, Inc. | LFZ |
| Mar 7, 1994 | K934137 | OPUS(R) SEROLOGY CONTROLS, MODIFICATION Pb Diagnostic Systems, Inc. | MJX |
| Dec 22, 1993 | K935229 | OPUS DIGITOXIN Pb Diagnostic Systems, Inc. | DPG |
| Nov 22, 1993 | K934705 | OPUS NAPA Pb Diagnostic Systems, Inc. | LAN |
| Sep 8, 1993 | K933675 | OPUS TOTAL CK Pb Diagnostic Systems, Inc. | CGS |
| Sep 8, 1993 | K933066 | OPUS ESTRADIOL Pb Diagnostic Systems, Inc. | CHP |
| Jul 8, 1993 | K932279 | OPUS(R) TOTAL B-HCG TEST SYSTEM Pb Diagnostic Systems, Inc. | JHI |
| Jun 7, 1993 | K926131 | OPUS MAGNUM ANALYZER Pb Diagnostic Systems, Inc. | KHO |
| Dec 11, 1992 | K924957 | OPUS(R) VANCOMYCIN Pb Diagnostic Systems, Inc. | LEH |
| Oct 15, 1992 | K924429 | OPUS(R) CK-MB Pb Diagnostic Systems, Inc. | JHY |
| Mar 18, 1992 | K915838 | OPUS FERRITIN TEST SYSTEM Pb Diagnostic Systems, Inc. | DGE |
| Mar 17, 1992 | K915850 | OPUS MYOGLOBIN TEST SYSTEM Pb Diagnostic Systems, Inc. | DDR |
| Nov 7, 1991 | K913938 | OPUS(R) LH TEST SYSTEM Pb Diagnostic Systems, Inc. | CEP |
| Sep 11, 1991 | K913295 | OPUS(R) PLUS ANALYZER Pb Diagnostic Systems, Inc. | JJQ |
| Aug 16, 1991 | K913280 | OPUS(R) PROLACTIN TEST SYSTEM Pb Diagnostic Systems, Inc. | CFT |
| Aug 12, 1991 | K911834 | OPUS(R) ROZO Pb Diagnostic Systems, Inc. | LGD |
| Jul 1, 1991 | K911940 | OPUS(R) TOBRAMYCIN Pb Diagnostic Systems, Inc. | LCR |
| Apr 17, 1991 | K905257 | OPUS CMV TEST SYSTEM Pb Diagnostic Systems, Inc. | LIN |
| Apr 16, 1991 | K911409 | OPUS FSH Pb Diagnostic Systems, Inc. | CGJ |
| Feb 21, 1991 | K905721 | OPUS GENTAMICIN Pb Diagnostic Systems, Inc. | LCQ |
| Feb 4, 1991 | K905410 | OPUS T3 TEST SYSTEM Pb Diagnostic Systems, Inc. | CDP |
| Jul 30, 1990 | K902797 | OPUS TM T-UPTAKE TEST SYSTEM Pb Diagnostic Systems, Inc. | KHQ |
| Jul 5, 1990 | K902333 | OPUS TSH TEST SYSTEM Pb Diagnostic Systems, Inc. | JLW |
| Jun 26, 1990 | K901935 | OPUS (TM) HCG Pb Diagnostic Systems, Inc. | JHI |
| Jun 26, 1990 | K901547 | OPUS(TM) DIGOXIN TEST SYSTEM Pb Diagnostic Systems, Inc. | KXT |
| Jun 26, 1990 | K901538 | MODIFIED OPUS VALPROIC ACID TEST SYSTEM Pb Diagnostic Systems, Inc. | LEG |
| Jun 12, 1990 | K901537 | MODIFIED OPUS PHENOBARBITAL TEST SYSTEM Pb Diagnostic Systems, Inc. | LET |
| Mar 19, 1990 | K897193 | OPUS T4 TEST SYSTEM Pb Diagnostic Systems, Inc. | KLI |
| Jan 11, 1990 | K896861 | OPUS PHENOBARBITAL TEST SYSTEM Pb Diagnostic Systems, Inc. | DLZ |
| Jan 2, 1990 | K896868 | OPUS PHENYTOIN TEST SYSTEM Pb Diagnostic Systems, Inc. | LGR |
| Jan 2, 1990 | K896860 | OPUS CARBAMAZEPINE TEST SYSTEM Pb Diagnostic Systems, Inc. | KLT |
| Aug 3, 1989 | K894159 | OPUS IMMUNOASSAY SYSTEM Pb Diagnostic Systems, Inc. | KHO |
| Dec 29, 1988 | K885044 | BEHRING POLAROID OPUS THEOPHYLLINE Pb Diagnostic Systems, Inc. | KLS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||