510(k) K842104
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 1984
- Date Received
- May 25, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colorimetric Method, Gamma-Glutamyl Transpeptidase
- Device Class
- Class I
- Regulation Number
- 862.1360
- Review Panel
- CH
- Submission Type