Submission Details
| 510(k) Number | K032296 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 25, 2003 |
| Decision Date | August 13, 2003 |
| Days to Decision | 19 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS
Aug 2003
Decision
19d
Days
Class 2
Risk
About This 510(k) Submission
K032296 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS, a Calibrator, Primary (Class II — Special Controls, product code JIS), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on August 13, 2003, 19 days after receiving the submission on July 25, 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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