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510(k) K884226

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

K884226 is an FDA 510(k) premarket notification submitted by A-Kem, Inc. for the device "AMYLASE REAGENT KIT FOR ASTRA SYSTEMS". The FDA issued a decision of Substantially Equivalent on December 9, 1988. The device falls under product code CJA (Amyloclastic, Amylase), a Class II device regulated under 21 CFR 862.1070. A-Kem, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K882586 — A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM (August 8, 1988)
  • K882587 — A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM (August 8, 1988)
  • K873129 — CARBON DIOXIDE REAGENT KIT (October 23, 1987)
  • K873130 — WASH SOLUTION KIT (October 23, 1987)
  • K873126 — SODIUM/POTASSIUM REAGENT KIT (October 23, 1987)
  • K873128 — GLUCOSE REAGENT KIT (October 23, 1987)
  • K873131 — CREATININE 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)

FDA data resources