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510(k) K895880

PANCREATIC A-AMYLASE EPS by Boehringer Mannheim Corp. — Product Code CIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1989
Date Received
October 5, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cresol Red Colorimetry, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type

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  • K983185 — BOEHRINGER MANNHEIM TINA-QUANT IGE TEST (November 12, 1998)
  • K982948 — ELECSYS PSA, MODEL # ELECSYS 1010 (October 27, 1998)

Other clearances for product code CIL

  • K922953 — SYSTEMATE CALCIUM TEST TECHNICON RA 1000 (September 9, 1992)
  • K833724 — ENZYMATIC CO2 (December 29, 1983)
  • K800111 — CO2 CONTENT (February 13, 1980)