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510(k) K990025

CARESIDE AMYLASE by Careside, Inc. — Product Code JFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1999
Date Received
January 4, 1999
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 Careside, Inc.

  • K020484 — CARESIDE LDH (July 3, 2002)
  • K020486 — CARESIDE GGT (July 1, 2002)
  • K020487 — CARESIDE ALT (June 4, 2002)
  • K020488 — CARESIDE TRGLYCERIDE (April 15, 2002)
  • K002792 — CARESIDE CHOLINESTERASE (November 8, 2000)
  • K001462 — CARESIDE HEMOGLOBIN (August 21, 2000)
  • K993771 — CARESIDE DIRECT BILIRUBIN (December 27, 1999)
  • K993634 — CARESIDE ANALYZER (December 2, 1999)
  • K992475 — CARESIDE CO2, TOTAL (September 15, 1999)
  • K991717 — CARESIDE MG (August 10, 1999)

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)