The following data is part of a premarket notification filed by Dade Intl., Inc. with the FDA for Paramax Alanine Aminotransferase (gpt) Reagent.
| Device ID | K951332 |
| 510k Number | K951332 |
| Device Name: | PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| Applicant | DADE INTL., INC. 1717 DEERFIELD RD. Deerfield, IL 60015 -0778 |
| Contact | David Jameson |
| Correspondent | David Jameson DADE INTL., INC. 1717 DEERFIELD RD. Deerfield, IL 60015 -0778 |
| Product Code | CKA |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-09 |
| Decision Date | 1995-06-19 |