Submission Details
| 510(k) Number | K032697 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 02, 2003 |
| Decision Date | November 07, 2003 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
Nov 2003
Decision
66d
Days
Class 2
Risk
About This 510(k) Submission
K032697 is an FDA 510(k) clearance for the DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414), a Calibrator, Primary (Class II — Special Controls, product code JIS), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on November 7, 2003, 66 days after receiving the submission on September 2, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.
Device Classification
| Product Code | JIS — Calibrator, Primary |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1150 |
Manufacturer
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