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510(k) K860245

ENZYMATIC ALPHA-AMYLASE REAGENT KIT by Bio-Analytics Laboratories, Inc. — Product Code JFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1986
Date Received
January 24, 1986
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 Bio-Analytics Laboratories, Inc.

  • K861638 — KINETIC ALKALINE PHOSPHATASE REAGENT KIT (May 29, 1986)
  • K860213 — ALBUMIN REAGENT KIT (February 11, 1986)
  • K851513 — ULTRA-VIOLET BUN REAGENT KIT (May 20, 1985)
  • K851514 — ULTRA-VIOLET GLUCOSE REAGENT (May 20, 1985)
  • K850639 — ENZYMATIC ALPHA-AMYLASE REAGENT KIT (March 5, 1985)
  • K832771 — ERYTHROCYTE TEST (October 28, 1983)
  • K832567 — ACETAMINOPHEN(PARACETAMOL (September 12, 1983)
  • K831414 — COLORIMETRIC BUN (June 16, 1983)
  • K821934 — BIO-CAL OPERATION CHECK KIT (July 20, 1982)
  • K813431 — SALICYLATES (March 25, 1982)

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  • K080823 — EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT (November 17, 2008)
  • K070064 — AMYLASE EPS REAGENT (May 22, 2007)
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  • K051447 — SENTINEL PANCREATIC AMYLASE (January 26, 2006)