Isolab, Inc.: FDA filings under this applicant name
FDA lists 44 510(k) clearances under the applicant name “Isolab, Inc.” (first 1977, latest 1996), across 29 product codes in 5 review panels. Median 510(k) review time under this name: 88 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 |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | 7 | 7 |
| GHM | Test, Sickle Cell | 4 | 4 |
| JCM | Control, Hemoglobin, Abnormal | 4 | 4 |
| DFT | Igm, Antigen, Antiserum, Control | 2 | 2 |
| JBD | System, Analysis, Electrophoretic Hemoglobin | 2 | 2 |
| LGL | Assay, Bart'S, Hemoglobin | 2 | 2 |
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 1 | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | 1 |
| DFI | Total Spinal-Fluid, Antigen, Antiserum, Control | 1 | 1 |
| GDX | Scalpel, One-Piece | 1 | 1 |
Plus 19 more product codes.
Review panels
- Hematology (26)
- Clinical Chemistry (11)
- Immunology (3)
- Microbiology (2)
- General and Plastic Surgery (1)
Most recent Isolab, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951014 | ISOLAB'S T4 TEST KIT | KLI | 1996-10-18 | 592 |
| K950481 | NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT | JIA | 1996-02-01 | 363 |
| K943547 | PHENYLALANINE TEST KIT | JNB | 1996-01-26 | 554 |
| K950803 | ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE | JJT | 1995-09-21 | 212 |
| K950415 | FLUOROSCAN NEONATAL | KHO | 1995-09-05 | 217 |
| K942276 | QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY | GIQ | 1995-01-20 | 255 |
| K942222 | QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS | JCM | 1995-01-20 | 259 |
| K944185 | ISOSCAN | JQT | 1994-11-17 | 83 |
| K934013 | RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT | CIN | 1994-04-26 | 251 |
| K923153 | HEMOCARD, HEMOGLOBIN C ASSAY | MLL | 1994-01-27 | 577 |
34 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Isolab, 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 Isolab, Inc.?
FDA lists 44 510(k) clearances under the applicant name “Isolab, Inc.” (first 1977, latest 1996), across 29 product codes in 5 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 Isolab, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Isolab, Inc. is 88 days.
Which FDA product codes appear under Isolab, Inc.?
The most frequent FDA product codes under this applicant name are LCP (Assay, Glycosylated Hemoglobin, 7); GHM (Test, Sickle Cell, 4); JCM (Control, Hemoglobin, Abnormal, 4).
Next steps
- See all 44 Isolab, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LCP, Isolab, 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.