The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model Df 109.
| Device ID | K053337 |
| 510k Number | K053337 |
| Device Name: | DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109 |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG. 500 M.S. 514; POX 6101 Newark, DE 19714 -6101 |
| Contact | Yuk-ting Lewis |
| Correspondent | Yuk-ting Lewis DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG. 500 M.S. 514; POX 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 | 2005-12-01 |
| Decision Date | 2006-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768014710 | K053337 | 000 |