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510(k) K882225

-AMYLASE EPS by Boehringer Mannheim Corp. — Product Code CIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1989
Date Received
May 26, 1988
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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  • K953211 — AMYLASE (ETHYLIDENE PNGPG7) KIT (June 21, 1996)
  • K951494 — AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) (December 11, 1995)
  • K940735 — LIQUID AMYLASE (CNPG3) REAGENT SET (August 1, 1994)
  • K940010 — DMA AMYLASE (DEMAND) PROCEDURE (March 11, 1994)
  • K931301 — OLYMPUS AMYLASE REAGENT (October 18, 1993)
  • K931141 — BIOTROL AMYLASE CNPG3 (May 26, 1993)
  • K873572 — IL 35260, IL TEST AMYLASE REAGENT (October 20, 1987)