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510(k) K915710

AMYLASE (COLORIMETRIC) REAGENT SET by Tech Intl. Co. — Product Code JFJ

K915710 is an FDA 510(k) premarket notification submitted by Tech Intl. Co. for the device "AMYLASE (COLORIMETRIC) REAGENT SET". The FDA issued a decision of Substantially Equivalent on January 30, 1992. The device falls under product code JFJ (Catalytic Methods, Amylase), a Class II device regulated under 21 CFR 862.1070. Tech Intl. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1992
Date Received
November 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catalytic Methods, Amylase
Device Class
Class II
Regulation Number
862.1070
Review Panel
CH
Submission Type

Other clearances by Tech Intl. Co.

  • K915704 — AMYLASE (KINETIC) REAGENT SET (June 28, 1996)
  • K915705 — ACID PHOSPHATASE REAGENT SET (February 27, 1992)
  • 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)
  • 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 JFJ

  • K210633 — Amylase2 (May 26, 2022)
  • K191454 — Atellica CH Amylase_2 (AMY_2) (July 30, 2019)
  • K182474 — alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIR (May 2, 2019)
  • K130685 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY (August 9, 2013)
  • K122858 — ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINIC (October 3, 2012)
  • K091846 — SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 (October 16, 2009)
  • K080823 — EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT (November 17, 2008)
  • K070064 — AMYLASE EPS REAGENT (May 22, 2007)
  • K062180 — ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM (October 2, 2006)
  • K051447 — SENTINEL PANCREATIC AMYLASE (January 26, 2006)

FDA data resources