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510(k) K940010

DMA AMYLASE (DEMAND) PROCEDURE by Data Medical Associates, Inc. — Product Code CIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1994
Date Received
January 4, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saccharogenic, Amylase
Device Class
Class II
Regulation Number
862.1070
Review Panel
CH
Submission Type

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Other clearances for product code CIJ

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  • K931301 — OLYMPUS AMYLASE REAGENT (October 18, 1993)
  • K931141 — BIOTROL AMYLASE CNPG3 (May 26, 1993)
  • K882225 — -AMYLASE EPS (January 3, 1989)
  • K873572 — IL 35260, IL TEST AMYLASE REAGENT (October 20, 1987)