Portable Medical Laboratories, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Portable Medical Laboratories, Inc.” (first 1985, latest 1988), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 51 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 |
|---|---|---|---|
| IBJ | Light, Microscope | 3 | 3 |
| LIB | Device, General Purpose, Microbiology, Diagnostic | 3 | 3 |
| FMF | Syringe, Piston | 1 | 1 |
| GHO | Hemocytometer | 1 | 1 |
| KSL | Solution, Copper Sulfate For Specific Gravity Determinations | 1 | 1 |
Review panels
- Microbiology (3)
- Pathology (3)
- Hematology (2)
- General Hospital (1)
Most recent Portable Medical Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882101 | HEMOGLOBIN SCREENING DEVICE | KSL | 1988-07-01 | 51 |
| K874190 | CELL COUNTING GRID GRATICULE | IBJ | 1988-01-05 | 83 |
| K871671 | URINOSCOPY FUNNEL | GHO | 1987-05-20 | 22 |
| K864049 | MCARTHUR MICROSCOPE, STANDARD METAL VERSION | IBJ | 1986-10-29 | 12 |
| K854735 | MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. | IBJ | 1985-12-10 | 15 |
| K844476 | PORTABLE DIAGNOSTIC LABORATORY | LIB | 1985-03-13 | 114 |
| K844475 | SPECIMEN COLLECTION & TRANSPORT SYSTEM | FMF | 1985-02-06 | 79 |
| K844442 | RAPID DIAGNOSTIC KIT | LIB | 1985-02-01 | 77 |
| K844473 | HAND-HELD SLIDE READER | LIB | 1985-01-04 | 46 |
Recalls
openFDA lists no recalls under a recalling firm named Portable Medical 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Portable Power Systems, Inc. (18 510(k)s)
- Portable Therapeutix (2 510(k)s)
- Portable Diagnostic Services, Inc. (1 510(k)s)
- Portable Ophthalmic Devices, Inc. (1 510(k)s)
- Portable Travtion Device Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Portable Medical Laboratories, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Portable Medical Laboratories, Inc.” (first 1985, latest 1988), across 5 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 Portable Medical Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Portable Medical Laboratories, Inc. is 51 days.
Which FDA product codes appear under Portable Medical Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are IBJ (Light, Microscope, 3); LIB (Device, General Purpose, Microbiology, Diagnostic, 3); FMF (Syringe, Piston, 1).
Next steps
- See all 9 Portable Medical Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IBJ, Portable Medical 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, 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.