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510(k) K040920

AMYLASE LIQUID REAGENT, MODEL A532-200 by Teco Diagnostics — Product Code JFJ

K040920 is an FDA 510(k) premarket notification submitted by Teco Diagnostics for the device "AMYLASE LIQUID REAGENT, MODEL A532-200". The FDA issued a decision of Substantially Equivalent on May 10, 2004. The device falls under product code JFJ (Catalytic Methods, Amylase), a Class II device regulated under 21 CFR 862.1070. Teco Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2004
Date Received
April 8, 2004
Clearance Type
Special
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 Teco Diagnostics

  • K170118 — Scanostics UTI Check Application Test System (September 21, 2017)
  • K161527 — Teco Creatinine Enzymatic Reagent Kit (July 21, 2017)
  • K170200 — Carbon Dioxide Reagent Set (June 1, 2017)
  • K160372 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (July 22, 2016)
  • K152835 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (March 7, 2016)
  • K141289 — TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS (July 24, 2015)
  • K131600 — URS-2GP (GLUCOSE PROTEIN) URINE STRIPS (May 29, 2014)
  • K111206 — TECO DIAGNOSTICS SALIVA ALCOHOL TEST (October 4, 2011)
  • K100024 — TECO DIAGNOSTICS UTI DETECTION STRIPS (February 17, 2011)
  • K101673 — URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 (February 4, 2011)

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