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510(k) K800693

STANBIO PROSTATIC ACID PHOSPHATASE TEST by Stanbio Laboratory — Product Code CKE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1980
Date Received
March 27, 1980
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)
  • K790524 — DATA-ZYME ACIA PHOSPHATASE PROCEDURE (May 23, 1979)