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510(k) K915705

ACID PHOSPHATASE REAGENT SET by Tech Intl. Co. — Product Code CKE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1992
Date Received
November 29, 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

Other clearances by Tech Intl. Co.

  • K915704 — AMYLASE (KINETIC) REAGENT SET (June 28, 1996)
  • K915707 — AMMONIA REAGENT SET (February 26, 1992)
  • K914158 — URIC ACID REAGENT SET (February 21, 1992)
  • K915706 — LIPASE REAGENT SET (February 18, 1992)
  • K914160 — CHOLESTEROL REGEANT SET (January 30, 1992)
  • K915710 — AMYLASE (COLORIMETRIC) REAGENT SET (January 30, 1992)
  • K914159 — GLUCOSE REAGENT SET (January 27, 1992)
  • K915709 — CREATINE KINASE-MB (CK-MB) REAGENT SET (January 27, 1992)
  • K915708 — INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET (January 22, 1992)
  • K914171 — IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE (December 18, 1991)

Other clearances for product code CKE

  • K914167 — CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE (March 17, 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)