The following data is part of a premarket notification filed by Bio-rad with the FDA for Manual Phenylalanine Test.
| Device ID | K963040 |
| 510k Number | K963040 |
| Device Name: | MANUAL PHENYLALANINE TEST |
| Classification | Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine |
| Applicant | BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Contact | Trevor Wall |
| Correspondent | Trevor Wall BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Product Code | JNB |
| CFR Regulation Number | 862.1555 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-05 |
| Decision Date | 1996-10-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817021527 | K963040 | 000 |