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510(k) K782032

UNITEST AMYLASE by Boehringer Mannheim Corp. — Product Code CIW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1979
Date Received
December 6, 1978
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

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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)
  • K850639 — ENZYMATIC ALPHA-AMYLASE REAGENT KIT (March 5, 1985)
  • K812027 — KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) (August 3, 1981)
  • K810584 — PHADEBAS ISOAMYLASE TEST (May 13, 1981)
  • K810669 — PANTRAK E.K. (March 31, 1981)