510(k) K903304
K903304 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ROCHE COBAS READY GGT REAGENT". The FDA issued a decision of Substantially Equivalent on October 12, 1990. The device falls under product code JPZ (Colorimetric Method, Gamma-Glutamyl Transpeptidase), a Class I device regulated under 21 CFR 862.1360. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 1990
- Date Received
- July 24, 1990
- 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