The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista System Bilirubin Calibrator, Model Kc210.
| Device ID | K072717 |
| 510k Number | K072717 |
| Device Name: | DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210 |
| Classification | Calibrator, Secondary |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; P.O. BOX 6101; MAIL BOX 514 Newark, DE 19714 -6101 |
| Contact | Helen M Lee |
| Correspondent | Helen M Lee DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; P.O. BOX 6101; MAIL BOX 514 Newark, DE 19714 -6101 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-25 |
| Decision Date | 2007-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768015823 | K072717 | 000 |