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510(k) K895423

ACCESS CHEMISTRY ANALYZER by American Monitor Corp. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1989
Date Received
September 7, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

Other clearances by American Monitor Corp.

  • K896000 — ASPARTATE AMINOTRANFERASE (AST) (January 11, 1990)
  • K895999 — PHOSPHORUS (January 11, 1990)
  • K896001 — ALANINE AMINOTRANSFERASE (ALT) (November 13, 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)
  • K883504 — DURAZYME(R) CPK (September 13, 1988)

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