K971060 is an FDA 510(k) clearance for the PRECINORM TDM CONTROLS. This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on July 7, 1997, 105 days after receiving the submission on March 24, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K971060 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1997 |
| Decision Date | July 07, 1997 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DIF — Drug Mixture Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |