Company ยท US
Intl. Immunoassay Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1992. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHW | U.V. Method, Cpk Isoenzymes | 5 |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | 5 |
| JHT | Chromatographic Separation, Cpk Isoenzymes | 4 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 2 |
| JHY | Colorimetric Method, Cpk Or Isoenzymes | 2 |
| KHE | Reagent, Occult Blood | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 1 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 22, 1992 | K913380 | MYDAS(TM)-MB2/MYDAS(TM)-MB Intl. Immunoassay Laboratories, Inc. | JHX |
| Oct 23, 1991 | K913349 | STAMBI-CK Intl. Immunoassay Laboratories, Inc. | JHW |
| Jul 8, 1991 | K912231 | PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT Intl. Immunoassay Laboratories, Inc. | JHW |
| Nov 6, 1990 | K903441 | MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS Intl. Immunoassay Laboratories, Inc. | JHX |
| Sep 7, 1990 | K903508 | LABELLING CHANGES TO IMPRES-MB-X Intl. Immunoassay Laboratories, Inc. | JHW |
| May 15, 1990 | K901450 | MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB Intl. Immunoassay Laboratories, Inc. | JHT |
| Mar 16, 1989 | K890609 | IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) Intl. Immunoassay Laboratories, Inc. | CGS |
| Mar 13, 1989 | K890543 | IMPRES-MB REAGENT A AND REAGENT B Intl. Immunoassay Laboratories, Inc. | JHX |
| Oct 31, 1988 | K883432 | IMMUNOCCULT-LXI Intl. Immunoassay Laboratories, Inc. | KHE |
| Sep 30, 1988 | K883223 | CHECK-MM Intl. Immunoassay Laboratories, Inc. | JHS |
| Sep 30, 1988 | K883222 | ISOFOR-MM (TM) Intl. Immunoassay Laboratories, Inc. | JHW |
| Jul 8, 1988 | K871143 | IMMUNOCCULT EIA TEST KIT Intl. Immunoassay Laboratories, Inc. | KHE |
| Jun 8, 1988 | K881801 | IMPRES-MB Intl. Immunoassay Laboratories, Inc. | JHW |
| Jun 1, 1988 | K881351 | IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225 Intl. Immunoassay Laboratories, Inc. | JHY |
| Dec 18, 1987 | K874545 | IMACK-MB TEST PROCEDURE (MODIFICATION) Intl. Immunoassay Laboratories, Inc. | JHY |
| Aug 3, 1987 | K872598 | MICROMI-CK(TM) Intl. Immunoassay Laboratories, Inc. | JHT |
| Jul 31, 1987 | K872592 | IMACK-MB(TM) Intl. Immunoassay Laboratories, Inc. | JHT |
| Sep 7, 1984 | K843007 | CARDI-CK EIA TEST KIT CK-MB ISOENZYME Intl. Immunoassay Laboratories, Inc. | JHS |
| Jul 27, 1982 | K821963 | EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT. Intl. Immunoassay Laboratories, Inc. | GGP |
| Jul 22, 1982 | K821964 | 125I QUICK-MB TEST KIT FOR QUANTITATION Intl. Immunoassay Laboratories, Inc. | JHT |
| Dec 22, 1981 | K813213 | SHARIA-LH RIA KIT FOR QUANTITATION HORMO Intl. Immunoassay Laboratories, Inc. | CEP |
| Dec 17, 1981 | K813087 | ABURIA-CK RIA TEST KIT Intl. Immunoassay Laboratories, Inc. | JHX |
| Dec 17, 1981 | K813086 | ANDRIA-FSH RIA TEST KIT Intl. Immunoassay Laboratories, Inc. | CGJ |
| Oct 2, 1981 | K812671 | EMBRITROL CK-MB CONTROLS Intl. Immunoassay Laboratories, Inc. | JJT |
| Aug 13, 1981 | K812112 | MARRIA-HPRL RIA KIT Intl. Immunoassay Laboratories, Inc. | CFT |
| Apr 29, 1981 | K811070 | 125 I-T4 RIA TEST KIT Intl. Immunoassay Laboratories, Inc. | CDX |
| Sep 26, 1980 | K801728 | EMBRIA-CK Intl. Immunoassay Laboratories, Inc. | JHX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||