K896170 is an FDA 510(k) clearance for the REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083. This device is classified as a Chromatographic Separation, Cpk Isoenzymes (Class II - Special Controls, product code JHT).
Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on February 16, 1990, 114 days after receiving the submission on October 25, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K896170 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1989 |
| Decision Date | February 16, 1990 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JHT — Chromatographic Separation, Cpk Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |