Submission Details
| 510(k) Number | K983674 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS
Jan 1999
Decision
101d
Days
Class 1
Risk
About This 510(k) Submission
K983674 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS, 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 review panel. Regulated under 21 CFR 862.1400.
Device Classification
| Product Code | JMM — Column Chromatography & Color Development, Hydroxyproline |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1400 |
Manufacturer
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