K864082 is an FDA 510(k) clearance for the REFLOTRON(R) ALT (GPT). This device is classified as a Hydrazone Colorimetry, Alt/sgpt (Class I - General Controls, product code CKD).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 4, 1986, 45 days after receiving the submission on October 20, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1030.
| 510(k) Number | K864082 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1986 |
| Decision Date | December 04, 1986 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CKD — Hydrazone Colorimetry, Alt/sgpt |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1030 |