Intl. Immunoassay Laboratories, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Intl. Immunoassay Laboratories, Inc.” (first 1980, latest 1992), across 13 product codes in 2 review panels. Median 510(k) review time under this name: 45 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 |
|---|---|---|---|
| JHW | U.V. Method, Cpk Isoenzymes | 5 | 5 |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | 5 | 5 |
| JHT | Chromatographic Separation, Cpk Isoenzymes | 4 | 4 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 2 | 2 |
| JHY | Colorimetric Method, Cpk Or Isoenzymes | 2 | 2 |
| KHE | Reagent, Occult Blood | 2 | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
Plus 3 more product codes.
Review panels
- Clinical Chemistry (24)
- Hematology (3)
Most recent Intl. Immunoassay Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913380 | MYDAS(TM)-MB2/MYDAS(TM)-MB | JHX | 1992-04-22 | 268 |
| K913349 | STAMBI-CK | JHW | 1991-10-23 | 89 |
| K912231 | PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT | JHW | 1991-07-08 | 49 |
| K903441 | MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS | JHX | 1990-11-06 | 98 |
| K903508 | LABELLING CHANGES TO IMPRES-MB-X | JHW | 1990-09-07 | 38 |
| K901450 | MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB | JHT | 1990-05-15 | 48 |
| K890609 | IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) | CGS | 1989-03-16 | 37 |
| K890543 | IMPRES-MB REAGENT A AND REAGENT B | JHX | 1989-03-13 | 38 |
| K883432 | IMMUNOCCULT-LXI | KHE | 1988-10-31 | 77 |
| K883223 | CHECK-MM | JHS | 1988-09-30 | 63 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Intl. Immunoassay 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.
- Intl. Diagnostic Technology (29 510(k)s)
- Intl. Medical, Inc. (17 510(k)s)
- Intl. Remote Imaging Systems (14 510(k)s)
- Intl. Medical Devices , Ltd. (12 510(k)s)
- Intl. Playtex, Inc. (10 510(k)s)
- Intl. Business Machines (8 510(k)s)
- Intl. Bioclinical, Inc. (6 510(k)s)
- Intl. Diagnostic, Inc. (6 510(k)s)
- Intl. Medical Consultants (6 510(k)s)
- Intl. Medical Equipment Corp. (6 510(k)s)
- Intl. Ophthalmic Industries Corp. (6 510(k)s)
- Intl. Trade Management Co. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intl. Immunoassay Laboratories, Inc.?
FDA lists 27 510(k) clearances under the applicant name “Intl. Immunoassay Laboratories, Inc.” (first 1980, latest 1992), across 13 product codes in 2 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 Intl. Immunoassay Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intl. Immunoassay Laboratories, Inc. is 45 days.
Which FDA product codes appear under Intl. Immunoassay Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are JHW (U.V. Method, Cpk Isoenzymes, 5); JHX (Fluorometric Method, Cpk Or Isoenzymes, 5); JHT (Chromatographic Separation, Cpk Isoenzymes, 4).
Next steps
- See all 27 Intl. Immunoassay Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHW, Intl. Immunoassay 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.