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510(k) K884226

AMYLASE REAGENT KIT FOR ASTRA SYSTEMS by A-Kem, Inc. — Product Code CJA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1988
Date Received
October 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by A-Kem, Inc.

  • K884224 — TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS (December 15, 1988)
  • K884227 — CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM (December 9, 1988)
  • K884225 — TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS (December 9, 1988)
  • K882587 — A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM (August 8, 1988)
  • K882586 — A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM (August 8, 1988)
  • K873128 — GLUCOSE REAGENT KIT (October 23, 1987)
  • K873130 — WASH SOLUTION KIT (October 23, 1987)
  • K873127 — CHLORIDE REAGENT KIT (October 23, 1987)
  • K873132 — BUN REAGENT KIT (October 23, 1987)
  • K873126 — SODIUM/POTASSIUM REAGENT KIT (October 23, 1987)

Other clearances for product code CJA

  • K895555 — MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) (December 22, 1989)
  • K883059 — WAKO(TM) AUTOKIT AMYLASE (August 30, 1988)
  • K873520 — PARAMAX AMYLASE REAGENT (November 23, 1987)
  • K862640 — AMYLASE LTS (September 9, 1986)
  • K863052 — ALPHA AMYLASE (September 9, 1986)
  • K860530 — AMYLASE REAGENT SET (MODIFIED CARAWAY) (February 28, 1986)
  • K844168 — AMYLASE REAGENT CS-726 (November 20, 1984)
  • K843529 — ASTRA SYSTEMS AMYLASE REAGENT KIT (October 11, 1984)
  • K833864 — AMYLASE REAGENT SET-MODIFIED CARAWAY (January 13, 1984)