K990992 is an FDA 510(k) clearance for the INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 30, 1999, 190 days after receiving the submission on March 24, 1999.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K990992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1999 |
| Decision Date | September 30, 1999 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LCP — Assay, Glycosylated Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7470 |