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510(k) K770504

REAGENT SYSTEM by American Monitor Corp. — Product Code JGZ

K770504 is an FDA 510(k) premarket notification submitted by American Monitor Corp. for the device "REAGENT SYSTEM". The FDA issued a decision of Substantially Equivalent on June 27, 1977. The device falls under product code JGZ (O-Phthalaldehyde, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. American Monitor Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1977
Date Received
March 16, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
O-Phthalaldehyde, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
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)
  • 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 JGZ

  • K904049 — ROCHE COBAS READY RENAL PROFILE REAGENT STRIP (October 12, 1990)
  • K896236 — COBAS READY BUN REAGENT (February 27, 1990)
  • K883327 — CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST (January 23, 1989)
  • K863901 — IQ UREA NITROGEN (November 24, 1986)
  • K842772 — PHARMACIA B2-MICRO RIA (November 1, 1984)
  • K840213 — BLOOD UREA NITROGEN REAGENT SYS (March 19, 1984)
  • K820418 — K.D. COLORIMETRIC BLOOD UREA N2 TEST (March 11, 1982)
  • K810087 — UREA NITROGEN, KINETIC (February 26, 1981)
  • K801269 — SERALYZER BLOOD UREA NITROGEN(BUN) (July 8, 1980)
  • K792362 — BLOOD UREA NITROGEN REAGENT (December 6, 1979)

FDA data resources