K934070 is an FDA 510(k) clearance for the TINA-QUANT HEMOGLOBIN A1C. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 11, 1994, 417 days after receiving the submission on August 20, 1993.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K934070 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1993 |
| Decision Date | October 11, 1994 |
| Days to Decision | 417 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | LCP — Assay, Glycosylated Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7470 |