510(k) K874903
K874903 is an FDA 510(k) premarket notification submitted by Simmler, Inc. for the device "MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)". The FDA issued a decision of Substantially Equivalent on Feb 11, 1988. The device falls under product code JPZ (Colorimetric Method, Gamma-Glutamyl Transpeptidase), a Class I device regulated under 21 CFR 862.1360. Simmler, Inc. has 22 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 11, 1988
- Date Received
- Dec 1, 1987
- 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
- 510(k) Exempt