510(k) K001266
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA by
Ortho-Clinical Diagnostics, Inc.
— Product Code CGN
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2000
- Date Received
- April 20, 2000
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid, Folic, Radioimmunoassay
- Device Class
- Class II
- Regulation Number
- 862.1295
- Review Panel
- CH
- Submission Type