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510(k) K810584

PHADEBAS ISOAMYLASE TEST by Pharmacia, Inc. — Product Code CIW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1981
Date Received
March 4, 1981
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)
  • K810669 — PANTRAK E.K. (March 31, 1981)
  • K782032 — UNITEST AMYLASE (March 2, 1979)