510(k) K850902

DATA ZYME ACID PHOSPHATASE PROCEDURE by Data Medical Associates, Inc. — Product Code CKB

K850902 is an FDA 510(k) premarket notification submitted by Data Medical Associates, Inc. for the device "DATA ZYME ACID PHOSPHATASE PROCEDURE". The FDA issued a decision of Substantially Equivalent on March 20, 1985. The device falls under product code CKB (Acid Phosphatase, Naphthyl Phosphate), a Class II device regulated under 21 CFR 862.1020. Data Medical Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1985
Date Received
March 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid Phosphatase, Naphthyl Phosphate
Device Class
Class II
Regulation Number
862.1020
Review Panel
CH
Submission Type