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 |