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510(k) K011843

GENZYME DIRECT-AMYLASE TEST REAGENT by Genzyme Corp. — Product Code JFJ

K011843 is an FDA 510(k) premarket notification submitted by Genzyme Corp. for the device "GENZYME DIRECT-AMYLASE TEST REAGENT". The FDA issued a decision of Substantially Equivalent on August 10, 2001. The device falls under product code JFJ (Catalytic Methods, Amylase), a Class II device regulated under 21 CFR 862.1070. Genzyme Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2001
Date Received
June 12, 2001
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 Genzyme Corp.

  • K061508 — OSOM INFLUENZA A&B TEST (June 12, 2006)
  • K051244 — GENZYME OSOM INFLUENZA A & B TEST (February 21, 2006)
  • K040241 — N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET (June 25, 2004)
  • K040868 — SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH (June 4, 2004)
  • K033864 — GENZYME OSOM TRICHOMONAS RAPID TEST (April 2, 2004)
  • K023544 — GENZYME CONTRAST II HCG URINE/SERUM TEST (January 16, 2003)
  • K021316 — ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTR (July 25, 2002)
  • K021019 — COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE (June 18, 2002)
  • K012532 — SEPRAGEL SINUS (October 30, 2001)
  • K000239 — GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL (March 21, 2000)

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