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510(k) K833724

ENZYMATIC CO2 by American Monitor Corp. — Product Code CIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1983
Date Received
October 24, 1983
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

Other clearances by American Monitor Corp.

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  • K896001 — ALANINE AMINOTRANSFERASE (ALT) (November 13, 1989)
  • K895423 — ACCESS CHEMISTRY ANALYZER (October 4, 1989)
  • K893137 — EXCEL (TM) CHEMISTRY ANALYZER (August 10, 1989)
  • K892331 — ENZYMATIC UREA NITROGEN REAGENT SET (June 20, 1989)
  • K893479 — CHOLESTEROL REAGENT SET (June 19, 1989)
  • K892002 — NEOCHROME(R) III GLUCOSE (June 12, 1989)
  • K890312 — GAMMA-GLUTAMYLTRANSFERASE (March 24, 1989)
  • K890034 — PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) (February 3, 1989)

Other clearances for product code CIL

  • K922953 — SYSTEMATE CALCIUM TEST TECHNICON RA 1000 (September 9, 1992)
  • K895880 — PANCREATIC A-AMYLASE EPS (December 19, 1989)
  • K800111 — CO2 CONTENT (February 13, 1980)