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510(k) K862640

AMYLASE LTS by Electro-Nucleonics Laboratories, Inc. — Product Code CJA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1986
Date Received
July 10, 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

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Other clearances for product code CJA

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  • K883059 — WAKO(TM) AUTOKIT AMYLASE (August 30, 1988)
  • K873520 — PARAMAX AMYLASE REAGENT (November 23, 1987)
  • 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)