The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Cx Alanine, Cx Aspartate Aminotransferase-pyridoxal-5-phosphate, Cx Creatine Phosphokinase-n-acetyl-l-cysteine.
| Device ID | K952427 |
| 510k Number | K952427 |
| Device Name: | CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. BOX 8000 Brea, CA 92821 -6208 |
| Contact | Don W Hart |
| Correspondent | Don W Hart BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. BOX 8000 Brea, CA 92821 -6208 |
| Product Code | CKA |
| Subsequent Product Code | CGS |
| Subsequent Product Code | CIT |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-24 |
| Decision Date | 1995-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590575106 | K952427 | 000 |
| 15099590575076 | K952427 | 000 |
| 15099590222666 | K952427 | 000 |