The following data is part of a premarket notification filed by Alladin Diagnostic, Inc. with the FDA for Leucine Aminopeptidase Reagent.
| Device ID | K844965 |
| 510k Number | K844965 |
| Device Name: | LEUCINE AMINOPEPTIDASE REAGENT |
| Classification | L-leucine-4-nitroanilide (colorimetric), Leucine Arylamidase |
| Applicant | ALLADIN DIAGNOSTIC, INC. 84 BAYARD LN. Princeton, NJ 08540 |
| Contact | Eliot Woodbridge |
| Correspondent | Eliot Woodbridge ALLADIN DIAGNOSTIC, INC. 84 BAYARD LN. Princeton, NJ 08540 |
| Product Code | JGG |
| CFR Regulation Number | 862.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-24 |
| Decision Date | 1985-03-05 |