The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Urine Barbiturates (barb) Screen Flex Reagent Cartridge, Catalog No. Df 96a.
| Device ID | K000459 |
| 510k Number | K000459 |
| Device Name: | URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | DADE BEHRING, INC. RT. 896, GLASCOW BLDG. 500 Newark, DE 19714 |
| Contact | Judy Mcinnis-berger |
| Correspondent | Judy Mcinnis-berger DADE BEHRING, INC. RT. 896, GLASCOW BLDG. 500 Newark, DE 19714 |
| Product Code | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-11 |
| Decision Date | 2000-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005862 | K000459 | 000 |