Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pb Diagnostic Systems, Inc. — Predicate Candidate Screening
35 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
182 days90th percentile
35clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K940507 | OPUS FT4 TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1994-07-28 | 176 | 0 |
| K934762 | OPUS PROCAINAMIDE TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1994-07-20 | 289 | 0 |
| K933389 | OPUS CMV-G | Pb Diagnostic Systems, Inc. | 1994-06-28 | 351 | 0 |
| K934137 | OPUS(R) SEROLOGY CONTROLS, MODIFICATION | Pb Diagnostic Systems, Inc. | 1994-03-07 | 194 | 0 |
| K935229 | OPUS DIGITOXIN | Pb Diagnostic Systems, Inc. | 1993-12-22 | 51 | 0 |
| K934705 | OPUS NAPA | Pb Diagnostic Systems, Inc. | 1993-11-22 | 53 | 0 |
| K933675 | OPUS TOTAL CK | Pb Diagnostic Systems, Inc. | 1993-09-08 | 42 | 0 |
| K933066 | OPUS ESTRADIOL | Pb Diagnostic Systems, Inc. | 1993-09-08 | 78 | 0 |
| K932279 | OPUS(R) TOTAL B-HCG TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1993-07-08 | 57 | 0 |
| K926131 | OPUS MAGNUM ANALYZER | Pb Diagnostic Systems, Inc. | 1993-06-07 | 182 | 0 |
| K924957 | OPUS(R) VANCOMYCIN | Pb Diagnostic Systems, Inc. | 1992-12-11 | 72 | 0 |
| K924429 | OPUS(R) CK-MB | Pb Diagnostic Systems, Inc. | 1992-10-15 | 44 | 0 |
| K915838 | OPUS FERRITIN TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1992-03-18 | 85 | 0 |
| K915850 | OPUS MYOGLOBIN TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1992-03-17 | 82 | 0 |
| K913938 | OPUS(R) LH TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1991-11-07 | 65 | 0 |
| K913295 | OPUS(R) PLUS ANALYZER | Pb Diagnostic Systems, Inc. | 1991-09-11 | 49 | 0 |
| K913280 | OPUS(R) PROLACTIN TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1991-08-16 | 23 | 0 |
| K911834 | OPUS(R) ROZO | Pb Diagnostic Systems, Inc. | 1991-08-12 | 109 | 0 |
| K911940 | OPUS(R) TOBRAMYCIN | Pb Diagnostic Systems, Inc. | 1991-07-01 | 61 | 0 |
| K905257 | OPUS CMV TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1991-04-17 | 147 | 0 |
| K911409 | OPUS FSH | Pb Diagnostic Systems, Inc. | 1991-04-16 | 15 | 0 |
| K905721 | OPUS GENTAMICIN | Pb Diagnostic Systems, Inc. | 1991-02-21 | 62 | 0 |
| K905410 | OPUS T3 TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1991-02-04 | 63 | 0 |
| K902797 | OPUS TM T-UPTAKE TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1990-07-30 | 34 | 0 |
| K902333 | OPUS TSH TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1990-07-05 | 42 | 0 |
| K901935 | OPUS (TM) HCG | Pb Diagnostic Systems, Inc. | 1990-06-26 | 57 | 0 |
| K901538 | MODIFIED OPUS VALPROIC ACID TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1990-06-26 | 85 | 0 |
| K901547 | OPUS(TM) DIGOXIN TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1990-06-26 | 84 | 0 |
| K901537 | MODIFIED OPUS PHENOBARBITAL TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1990-06-12 | 71 | 0 |
| K897193 | OPUS T4 TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1990-03-19 | 80 | 0 |
| K896861 | OPUS PHENOBARBITAL TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1990-01-11 | 37 | 0 |
| K896860 | OPUS CARBAMAZEPINE TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1990-01-02 | 28 | 0 |
| K896868 | OPUS PHENYTOIN TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1990-01-02 | 26 | 0 |
| K894159 | OPUS IMMUNOASSAY SYSTEM | Pb Diagnostic Systems, Inc. | 1989-08-03 | 50 | 0 |
| K885044 | BEHRING POLAROID OPUS THEOPHYLLINE | Pb Diagnostic Systems, Inc. | 1988-12-29 | 24 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda