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510(k) K850639

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1985
Date Received
February 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Starch-Dye Bound Polymer, Amylase
Device Class
Class II
Regulation Number
862.1070
Review Panel
CH
Submission Type

Other clearances by Bio-Analytics Laboratories, Inc.

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  • K860213 — ALBUMIN REAGENT KIT (February 11, 1986)
  • K851513 — ULTRA-VIOLET BUN REAGENT KIT (May 20, 1985)
  • K851514 — ULTRA-VIOLET GLUCOSE REAGENT (May 20, 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)

Other clearances for product code CIW

  • K931559 — DMA AMYLASE PROCEDURE (October 28, 1993)
  • K924339 — OLYMPUS AMYLASE REAGENT (October 19, 1992)
  • K884382 — AMYLASE TEST (AMYL) ITEM NUMBER: 65653 (January 11, 1989)
  • K812027 — KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) (August 3, 1981)
  • K810584 — PHADEBAS ISOAMYLASE TEST (May 13, 1981)
  • K810669 — PANTRAK E.K. (March 31, 1981)
  • K782032 — UNITEST AMYLASE (March 2, 1979)