K983674 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS. This device is classified as a Column Chromatography & Color Development, Hydroxyproline (Class I - General Controls, product code JMM).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on January 29, 1999, 101 days after receiving the submission on October 20, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1400.
| 510(k) Number | K983674 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1998 |
| Decision Date | January 29, 1999 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JMM — Column Chromatography & Color Development, Hydroxyproline |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1400 |