Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intl. Immunoassay Laboratories, Inc. · Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
45 daysmedian FDA review time
98 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K913380 | MYDAS(TM)-MB2/MYDAS(TM)-MB | Intl. Immunoassay Laboratories, Inc. | 1992-04-22 | 268 | 0 |
| K913349 | STAMBI-CK | Intl. Immunoassay Laboratories, Inc. | 1991-10-23 | 89 | 0 |
| K912231 | PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT | Intl. Immunoassay Laboratories, Inc. | 1991-07-08 | 49 | 0 |
| K903441 | MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS | Intl. Immunoassay Laboratories, Inc. | 1990-11-06 | 98 | 0 |
| K903508 | LABELLING CHANGES TO IMPRES-MB-X | Intl. Immunoassay Laboratories, Inc. | 1990-09-07 | 38 | 0 |
| K901450 | MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB | Intl. Immunoassay Laboratories, Inc. | 1990-05-15 | 48 | 0 |
| K890609 | IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) | Intl. Immunoassay Laboratories, Inc. | 1989-03-16 | 37 | 0 |
| K890543 | IMPRES-MB REAGENT A AND REAGENT B | Intl. Immunoassay Laboratories, Inc. | 1989-03-13 | 38 | 0 |
| K883432 | IMMUNOCCULT-LXI | Intl. Immunoassay Laboratories, Inc. | 1988-10-31 | 77 | 0 |
| K883223 | CHECK-MM | Intl. Immunoassay Laboratories, Inc. | 1988-09-30 | 63 | 0 |
| K883222 | ISOFOR-MM (TM) | Intl. Immunoassay Laboratories, Inc. | 1988-09-30 | 63 | 0 |
| K871143 | IMMUNOCCULT EIA TEST KIT | Intl. Immunoassay Laboratories, Inc. | 1988-07-08 | 473 | 0 |
| K881801 | IMPRES-MB | Intl. Immunoassay Laboratories, Inc. | 1988-06-08 | 42 | 0 |
| K881351 | IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225 | Intl. Immunoassay Laboratories, Inc. | 1988-06-01 | 63 | 0 |
| K874545 | IMACK-MB TEST PROCEDURE (MODIFICATION) | Intl. Immunoassay Laboratories, Inc. | 1987-12-18 | 45 | 0 |
| K872598 | MICROMI-CK(TM) | Intl. Immunoassay Laboratories, Inc. | 1987-08-03 | 32 | 0 |
| K872592 | IMACK-MB(TM) | Intl. Immunoassay Laboratories, Inc. | 1987-07-31 | 30 | 0 |
| K843007 | CARDI-CK EIA TEST KIT CK-MB ISOENZYME | Intl. Immunoassay Laboratories, Inc. | 1984-09-07 | 38 | 0 |
| K821963 | EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT. | Intl. Immunoassay Laboratories, Inc. | 1982-07-27 | 26 | 0 |
| K821964 | 125I QUICK-MB TEST KIT FOR QUANTITATION | Intl. Immunoassay Laboratories, Inc. | 1982-07-22 | 21 | 0 |
| K813213 | SHARIA-LH RIA KIT FOR QUANTITATION HORMO | Intl. Immunoassay Laboratories, Inc. | 1981-12-22 | 43 | 0 |
| K813086 | ANDRIA-FSH RIA TEST KIT | Intl. Immunoassay Laboratories, Inc. | 1981-12-17 | 45 | 0 |
| K813087 | ABURIA-CK RIA TEST KIT | Intl. Immunoassay Laboratories, Inc. | 1981-12-17 | 45 | 0 |
| K812671 | EMBRITROL CK-MB CONTROLS | Intl. Immunoassay Laboratories, Inc. | 1981-10-02 | 11 | 0 |
| K812112 | MARRIA-HPRL RIA KIT | Intl. Immunoassay Laboratories, Inc. | 1981-08-13 | 17 | 0 |
| K811070 | 125 I-T4 RIA TEST KIT | Intl. Immunoassay Laboratories, Inc. | 1981-04-29 | 9 | 0 |
| K801728 | EMBRIA-CK | Intl. Immunoassay Laboratories, Inc. | 1980-09-26 | 64 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda