K864208 is an FDA 510(k) clearance for the VISION (TM) GGTP. This device is classified as a Colorimetric Method, Gamma-glutamyl Transpeptidase (Class I - General Controls, product code JPZ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 24, 1986, 28 days after receiving the submission on October 27, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1360.
| 510(k) Number | K864208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1986 |
| Decision Date | November 24, 1986 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JPZ — Colorimetric Method, Gamma-glutamyl Transpeptidase |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1360 |