Pb Diagnostic Systems, Inc.: FDA filings under this applicant name
FDA lists 35 510(k) clearances under the applicant name “Pb Diagnostic Systems, Inc.” (first 1988, latest 1994), across 33 product codes in 4 review panels. Median 510(k) review time under this name: 62 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 2 |
| KHO | Fluorometer, For Clinical Use | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 | 1 |
Plus 23 more product codes.
Review panels
- Clinical Chemistry (16)
- Clinical Toxicology (13)
- Microbiology (4)
- Immunology (2)
Most recent Pb Diagnostic Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940507 | OPUS FT4 TEST SYSTEM | CEC | 1994-07-28 | 176 |
| K934762 | OPUS PROCAINAMIDE TEST SYSTEM | LAR | 1994-07-20 | 289 |
| K933389 | OPUS CMV-G | LFZ | 1994-06-28 | 351 |
| K934137 | OPUS(R) SEROLOGY CONTROLS, MODIFICATION | MJX | 1994-03-07 | 194 |
| K935229 | OPUS DIGITOXIN | DPG | 1993-12-22 | 51 |
| K934705 | OPUS NAPA | LAN | 1993-11-22 | 53 |
| K933675 | OPUS TOTAL CK | CGS | 1993-09-08 | 42 |
| K933066 | OPUS ESTRADIOL | CHP | 1993-09-08 | 78 |
| K932279 | OPUS(R) TOTAL B-HCG TEST SYSTEM | JHI | 1993-07-08 | 57 |
| K926131 | OPUS MAGNUM ANALYZER | KHO | 1993-06-07 | 182 |
25 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pb Diagnostic Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Pb Diagnostic Systems, Inc.?
FDA lists 35 510(k) clearances under the applicant name “Pb Diagnostic Systems, Inc.” (first 1988, latest 1994), across 33 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pb Diagnostic Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pb Diagnostic Systems, Inc. is 62 days.
Which FDA product codes appear under Pb Diagnostic Systems, Inc.?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 2); KHO (Fluorometer, For Clinical Use, 2); CDP (Radioimmunoassay, Total Triiodothyronine, 1).
Next steps
- See all 35 Pb Diagnostic Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHI, Pb Diagnostic Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.