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510(k) K830616

ACTIVATED URIC ACID by American Monitor Corp. — Product Code CHD

K830616 is an FDA 510(k) premarket notification submitted by American Monitor Corp. for the device "ACTIVATED URIC ACID". The FDA issued a decision of Substantially Equivalent on April 5, 1983. The device falls under product code CHD (Acid, Ferric Ion-Sulfuric, Cholesterol), a Class I device regulated under 21 CFR 862.1175. American Monitor Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1983
Date Received
February 28, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Ferric Ion-Sulfuric, Cholesterol
Device Class
Class I
Regulation Number
862.1175
Review Panel
CH
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)

Other clearances for product code CHD

  • K841052 — CHOLESTEROL REAGENT SET (May 1, 1984)
  • K821195 — CHOLESTEROL REAGENT SET (July 13, 1982)

FDA data resources