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510(k) K862964

ANTIASTHMATIC CALIBRATORS by American Monitor Corp. — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1986
Date Received
August 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Specific
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

Other clearances by American Monitor Corp.

  • K895999 — PHOSPHORUS (January 11, 1990)
  • K896000 — ASPARTATE AMINOTRANFERASE (AST) (January 11, 1990)
  • 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)

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  • K033601 — LABONE MICRO-PLATE COTININE EIA (February 10, 2004)