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510(k) K863052

ALPHA AMYLASE by J. D. Assoc. — Product Code CJA

K863052 is an FDA 510(k) premarket notification submitted by J. D. Assoc. for the device "ALPHA AMYLASE". The FDA issued a decision of Substantially Equivalent on September 9, 1986. The device falls under product code CJA (Amyloclastic, Amylase), a Class II device regulated under 21 CFR 862.1070. J. D. Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1986
Date Received
August 12, 1986
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 J. D. Assoc.

  • K863103 — PEG 6,000 (January 13, 1987)
  • K863054 — AST S.C.E. (GOT) (January 13, 1987)
  • K863069 — MAGNESIOMETER (December 31, 1986)
  • K863079 — CREATINKINETIC (December 12, 1986)
  • K863053 — ALT S.C.E. (GPT) (December 10, 1986)
  • K863112 — PROTEINMETER (December 10, 1986)
  • K863068 — LDH S.C.E. (December 10, 1986)
  • K863066 — TRANSFERMETER (December 4, 1986)
  • K863102 — GLUCOMETER-E (November 24, 1986)
  • K863109 — FERROFAST (November 24, 1986)

Other clearances for product code CJA

  • K895555 — MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) (December 22, 1989)
  • K884226 — AMYLASE REAGENT KIT FOR ASTRA SYSTEMS (December 9, 1988)
  • K883059 — WAKO(TM) AUTOKIT AMYLASE (August 30, 1988)
  • K873520 — PARAMAX AMYLASE REAGENT (November 23, 1987)
  • K862640 — AMYLASE LTS (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