Submission Details
| 510(k) Number | K081543 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 02, 2008 |
| Decision Date | October 23, 2008 |
| Days to Decision | 143 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
Oct 2008
Decision
143d
Days
Class 2
Risk
About This 510(k) Submission
K081543 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on October 23, 2008, 143 days after receiving the submission on June 2, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.
Device Classification
| Product Code | JLW — Radioimmunoassay, Thyroid-stimulating Hormone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1690 |
Manufacturer
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