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510(k) K770504

REAGENT SYSTEM by American Monitor Corp. — Product Code JGZ

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

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  • 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)