The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Free Thyroxine Flex Reagent Cartridge And Loci 1 Calibrator.
| Device ID | K053531 |
| 510k Number | K053531 |
| Device Name: | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark, DE 19714 -6101 |
| Contact | Lorraine H Piestrak |
| Correspondent | Lorraine H Piestrak DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark, DE 19714 -6101 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-19 |
| Decision Date | 2006-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768016714 | K053531 | 000 |