The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Total Triiodothyronine Calibrator (rc414).
| Device ID | K032697 |
| 510k Number | K032697 |
| Device Name: | DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) |
| Classification | Calibrator, Primary |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY P.O. BOX 6101, BUILDING 500 Newark, DE 19714 |
| Contact | Lorraine H Piestrak |
| Correspondent | Lorraine H Piestrak DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY P.O. BOX 6101, BUILDING 500 Newark, DE 19714 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-02 |
| Decision Date | 2003-11-07 |
| Summary: | summary |