The following data is part of a premarket notification filed by Dade Intl., Inc. with the FDA for Vancomycin Flex Reagent Cartridge.
| Device ID | K963267 |
| 510k Number | K963267 |
| Device Name: | VANCOMYCIN FLEX REAGENT CARTRIDGE |
| Classification | Radioimmunoassay, Vancomycin |
| Applicant | DADE INTL., INC. BUILDING 500, MAILBOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Carolyn K George |
| Correspondent | Carolyn K George DADE INTL., INC. BUILDING 500, MAILBOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | LEH |
| CFR Regulation Number | 862.3950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-20 |
| Decision Date | 1996-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005763 | K963267 | 000 |