The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Urine Amphetamine/methamphetamine Screen Flex Reagent Cartridge.
| Device ID | K040133 |
| 510k Number | K040133 |
| Device Name: | URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Andrea M Tasker |
| Correspondent | Andrea M Tasker DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-21 |
| Decision Date | 2004-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005817 | K040133 | 000 |