510(k) K971566
K971566 is an FDA 510(k) premarket notification submitted by Horizon Diagnostics, Inc. for the device "CREATINE KINASE-MB REAGENT SET". The FDA issued a decision of Substantially Equivalent on July 14, 1997. The device falls under product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Horizon Diagnostics, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 1997
- Date Received
- April 29, 1997
- 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