The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Etoh Flex Reagent Cartridge (df22).
| Device ID | K071811 |
| 510k Number | K071811 |
| Device Name: | ETOH FLEX REAGENT CARTRIDGE (DF22) |
| Classification | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; P.O. BOX 6101; MAIL BOX 514 Newark, DE 19714 -6101 |
| Contact | Victor M Carrio |
| Correspondent | Victor M Carrio DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; P.O. BOX 6101; MAIL BOX 514 Newark, DE 19714 -6101 |
| Product Code | DIC |
| CFR Regulation Number | 862.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-03 |
| Decision Date | 2007-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768022050 | K071811 | 000 |