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510(k) K915705

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

K915705 is an FDA 510(k) premarket notification submitted by Tech Intl. Co. for the device "ACID PHOSPHATASE REAGENT SET". The FDA issued a decision of Substantially Equivalent on February 27, 1992. The device falls under product code CKE (Acid Phosphatase, Thymolphthale Inmonophosphate), a Class II device regulated under 21 CFR 862.1020. Tech Intl. Co. has at least 10 other 510(k) clearances on record.

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)
  • K915710 — AMYLASE (COLORIMETRIC) REAGENT SET (January 30, 1992)
  • K914160 — CHOLESTEROL REGEANT SET (January 30, 1992)
  • K915709 — CREATINE KINASE-MB (CK-MB) REAGENT SET (January 27, 1992)
  • K914159 — GLUCOSE 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)

FDA data resources