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510(k) K914167

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

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

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Other clearances for product code CKE

  • 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)
  • K790524 — DATA-ZYME ACIA PHOSPHATASE PROCEDURE (May 23, 1979)