The following data is part of a premarket notification filed by Advantage Diagnostics Corp. with the FDA for Redi-test Opiates.
| Device ID | K991883 |
| 510k Number | K991883 |
| Device Name: | REDI-TEST OPIATES |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | ADVANTAGE DIAGNOSTICS CORP. 3573 WESTWIND BLVD. Santa Rosa, CA 95403 |
| Contact | Janis Freestone |
| Correspondent | Janis Freestone ADVANTAGE DIAGNOSTICS CORP. 3573 WESTWIND BLVD. Santa Rosa, CA 95403 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-02 |
| Decision Date | 1999-09-15 |
| Summary: | summary |