510(k) K854501
K854501 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "CK(OPTIMIZED) REAGENT". The FDA issued a decision of Substantially Equivalent on Dec 4, 1985. The device falls under product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 4, 1985
- Date Received
- Nov 12, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- Device Class
- Class II
- Regulation Number
- 862.1215
- Review Panel
- CH
- Submission Type
- 510(k)