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510(k) K790524

DATA-ZYME ACIA PHOSPHATASE PROCEDURE by Data Medical Associates, Inc. — Product Code CKE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1979
Date Received
March 15, 1979
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

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Other clearances for product code CKE

  • K914167 — CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE (March 17, 1992)
  • K915705 — ACID PHOSPHATASE REAGENT SET (February 27, 1992)
  • K873726 — ACID PHOSPHATASE TEST (January 27, 1988)
  • K864230 — DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM (November 28, 1986)
  • K860476 — ACID PHOSPHATASE REAGENT SET (March 5, 1986)
  • K843380 — ACID PHOSPHATASE ASSAY KIT (September 20, 1984)
  • K821526 — ACID PHOSPHATASE REAGENT SET (June 10, 1982)
  • K800693 — STANBIO PROSTATIC ACID PHOSPHATASE TEST (April 16, 1980)