510(k) K983674
VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS by
Ortho-Clinical Diagnostics, Inc.
— Product Code JMM
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1999
- Date Received
- October 20, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Column Chromatography & Color Development, Hydroxyproline
- Device Class
- Class I
- Regulation Number
- 862.1400
- Review Panel
- CH
- Submission Type