The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Urine Opiates (opi) Screen Flex Reagent Cartridge, Catalog No. Df93a.
| Device ID | K003209 |
| 510k Number | K003209 |
| Device Name: | URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Contact | Cathy P Craft |
| Correspondent | Cathy P Craft DADE BEHRING, INC. P.O. BOX 6101 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-13 |
| Decision Date | 2000-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005831 | K003209 | 000 |