The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Dmac Indole Reagent.
| Device ID | K901390 |
| 510k Number | K901390 |
| Device Name: | DMAC INDOLE REAGENT |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | ANALYTICAL PRODUCTS, INC. 200 EXPRESS STREET Plainview , NY 11803 - |
| Contact | Valerie L Vargo |
| Correspondent | Valerie L Vargo ANALYTICAL PRODUCTS, INC. 200 EXPRESS STREET Plainview , NY 11803 - |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-26 |
| Decision Date | 1990-04-16 |