The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Phenylalanine Test Kit.
| Device ID | K943547 |
| 510k Number | K943547 |
| Device Name: | PHENYLALANINE TEST KIT |
| Classification | Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine |
| Applicant | ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Contact | Janet D Perkins |
| Correspondent | Janet D Perkins ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Product Code | JNB |
| CFR Regulation Number | 862.1555 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-21 |
| Decision Date | 1996-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438147001293 | K943547 | 000 |
| 06438147001286 | K943547 | 000 |