The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dgtx Flex Reagent Cartridge, Model Df36.
| Device ID | K990251 |
| 510k Number | K990251 |
| Device Name: | DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 |
| Classification | Enzyme Immunoassay, Digitoxin |
| Applicant | DADE BEHRING, INC. BLDG. 500 MAIL BOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Cathy P Craft |
| Correspondent | Cathy P Craft DADE BEHRING, INC. BLDG. 500 MAIL BOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | LFM |
| CFR Regulation Number | 862.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-27 |
| Decision Date | 1999-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005510 | K990251 | 000 |