Pasco Laboratories, Inc.: FDA filings under this applicant name
FDA lists 66 510(k) clearances under the applicant name “Pasco Laboratories, Inc.” (first 1978, latest 2004), plus 1 PMA decision, across 9 product codes in 3 review panels. Median 510(k) review time under this name: 66 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 |
|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 39 | 39 |
| JTN | Susceptibility Test Discs, Antimicrobial | 16 | 16 |
| LTT | Panels, Test, Susceptibility, Antimicrobial | 6 | 5 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | 1 |
| JSF | Culture Media, Single Biochemical Test | 1 | 1 |
| JTT | Susceptibility Test Powders, Antimicrobial | 1 | 1 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 1 | 1 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | 1 | 1 |
| LQM | Gram Negative Identification Panel | 1 | 1 |
Review panels
- Microbiology (65)
- Clinical Chemistry (1)
- Orthopedic (1)
Most recent Pasco Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042331 | PASCO MIC AND MIC/ID PANELS | JWY | 2004-10-07 | 38 |
| K041776 | PASCO MIC AND MIC/ID PANELS | JWY | 2004-08-03 | 33 |
| K041214 | PASCO MIC AND MIC/ID PANELS | JWY | 2004-06-07 | 28 |
| K033119 | PASCO MIC AND MIC/ID PANELS | JWY | 2003-11-18 | 49 |
| K031727 | PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN | JWY | 2003-07-30 | 57 |
| K031205 | PASCO MIC AND MIC/ID PANELS | JWY | 2003-06-13 | 58 |
| K031103 | PASCO MIC AND MIC/ID PANELS (ERTAPENEM) | JWY | 2003-06-12 | 66 |
| K030933 | PASCO MIC AND MIC/ID PANELS | JWY | 2003-05-01 | 37 |
| K030620 | PASCO MIC AND MIC/ID PANELS | LTT | 2003-04-14 | 46 |
| K020331 | PASCO MIC AND MIC/ID PANELS | JWY | 2002-03-20 | 48 |
56 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N50494 | PMA | MIC ANTIBIOTIC TEST PANELS | 1980-04-25 |
Recalls
openFDA lists no recalls under a recalling firm named Pasco Laboratories, 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 Pasco Laboratories, Inc.?
FDA lists 66 510(k) clearances under the applicant name “Pasco Laboratories, Inc.” (first 1978, latest 2004), plus 1 PMA decision, across 9 product codes in 3 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 Pasco Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pasco Laboratories, Inc. is 66 days.
Which FDA product codes appear under Pasco Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are JWY (Manual Antimicrobial Susceptibility Test Systems, 39); JTN (Susceptibility Test Discs, Antimicrobial, 16); LTT (Panels, Test, Susceptibility, Antimicrobial, 6).
Next steps
- See all 66 Pasco Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWY, Pasco Laboratories, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.