The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Myo Reagent Cartridge And Calibrator.
| Device ID | K053576 |
| 510k Number | K053576 |
| Device Name: | DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Contact | George M Plummer |
| Correspondent | George M Plummer DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, 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 | 2005-12-22 |
| Decision Date | 2006-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768016509 | K053576 | 000 |
| 00842768015335 | K053576 | 000 |