K810963 is an FDA 510(k) clearance for the BIO SET TM SUBSTRATE CALIBRATORS. This device is classified as a Calibrator, Primary (Class II - Special Controls, product code JIS).
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1981, 9 days after receiving the submission on April 8, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K810963 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 1981 |
| Decision Date | April 17, 1981 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JIS — Calibrator, Primary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |