Intl. Immunoassay Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 27
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K913380 | MYDAS(TM)-MB2/MYDAS(TM)-MB | April 22, 1992 |
| K913349 | STAMBI-CK | October 23, 1991 |
| K912231 | PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT | July 8, 1991 |
| K903441 | MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS | November 6, 1990 |
| K903508 | LABELLING CHANGES TO IMPRES-MB-X | September 7, 1990 |
| K901450 | MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB | May 15, 1990 |
| K890609 | IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) | March 16, 1989 |
| K890543 | IMPRES-MB REAGENT A AND REAGENT B | March 13, 1989 |
| K883432 | IMMUNOCCULT-LXI | October 31, 1988 |
| K883222 | ISOFOR-MM (TM) | September 30, 1988 |
| K883223 | CHECK-MM | September 30, 1988 |
| K871143 | IMMUNOCCULT EIA TEST KIT | July 8, 1988 |
| K881801 | IMPRES-MB | June 8, 1988 |
| K881351 | IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225 | June 1, 1988 |
| K874545 | IMACK-MB TEST PROCEDURE (MODIFICATION) | December 18, 1987 |
| K872598 | MICROMI-CK(TM) | August 3, 1987 |
| K872592 | IMACK-MB(TM) | July 31, 1987 |
| K843007 | CARDI-CK EIA TEST KIT CK-MB ISOENZYME | September 7, 1984 |
| K821963 | EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT. | July 27, 1982 |
| K821964 | 125I QUICK-MB TEST KIT FOR QUANTITATION | July 22, 1982 |