510(k) K850319
K850319 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT". The FDA issued a decision of Substantially Equivalent on Feb 12, 1985. The device falls under product code JQB (Kinetic Method, Gamma-Glutamyl Transpeptidase), a Class I device regulated under 21 CFR 862.1360. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 12, 1985
- Date Received
- Jan 28, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Kinetic Method, Gamma-Glutamyl Transpeptidase
- Device Class
- Class I
- Regulation Number
- 862.1360
- Review Panel
- CH
- Submission Type
- 510(k) Exempt