K943547 is an FDA 510(k) clearance for the PHENYLALANINE TEST KIT. This device is classified as a Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine (Class II - Special Controls, product code JNB).
Submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on January 26, 1996, 554 days after receiving the submission on July 21, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1555.
| 510(k) Number | K943547 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 1994 |
| Decision Date | January 26, 1996 |
| Days to Decision | 554 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JNB — Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1555 |