510(k) K914167

CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE by Eastman Kodak Company — Product Code CKE

K914167 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE". The FDA issued a decision of Substantially Equivalent on March 17, 1992. The device falls under product code CKE (Acid Phosphatase, Thymolphthale Inmonophosphate), a Class II device regulated under 21 CFR 862.1020. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1992
Date Received
September 17, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid Phosphatase, Thymolphthale Inmonophosphate
Device Class
Class II
Regulation Number
862.1020
Review Panel
CH
Submission Type