The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Total Iron Binding Capacity (ibct) Flex Reagent Cartridge.
| Device ID | K994115 |
| 510k Number | K994115 |
| Device Name: | TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE |
| Classification | Ferrozine (colorimetric) Iron Binding Capacity |
| Applicant | DADE BEHRING, INC. BLDG. 500 MAIL BOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Robin O Norris |
| Correspondent | Robin O Norris DADE BEHRING, INC. BLDG. 500 MAIL BOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JMO |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-06 |
| Decision Date | 2000-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005756 | K994115 | 000 |