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510(k) K771830

BLOOD UREA NITROGEN BUN by Gamma Enterprises, Inc. — Product Code CDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1977
Date Received
September 21, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diacetyl-Monoxime, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by Gamma Enterprises, Inc.

  • K790578 — GAMMA SMAC REAGENTS (May 15, 1979)
  • K780507 — SERUM GLUTAMIC-PYRUVIC TRANSAMINASE (May 3, 1978)
  • K780506 — CARBON DIOXIDE REAGENTS (May 3, 1978)
  • K780504 — CREATINE PHOSPHOKINASE (CPK) (May 3, 1978)
  • K780505 — SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE (May 3, 1978)
  • K771843 — WETTING AGENTS (November 22, 1977)
  • K771832 — CHLORIDE (November 22, 1977)
  • K771836 — LACTATE DEHYDROGENASE (November 22, 1977)
  • K771834 — CREATININE (November 3, 1977)
  • K771838 — SERUM IRON (November 3, 1977)

Other clearances for product code CDW

  • K874532 — BLOOD UREA NITROGEN (January 5, 1988)
  • K871320 — FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 (April 22, 1987)
  • K863425 — AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 (October 1, 1986)
  • K861775 — TWIN BUN/GLUCOSE (June 27, 1986)
  • K860419 — UREA NITROGEN REAGENT SET (February 11, 1986)
  • K850937 — UREA (June 10, 1985)
  • K844156 — UREA NITROGEN REAGENT SET (November 13, 1984)
  • K841068 — UREA NITROGEN REAGENT SET (May 1, 1984)
  • K822323 — ULTRACHEM BUN-UV, 65080 & 65081 (September 2, 1982)
  • K821212 — UREA NITROGEN REAGENT SET (July 22, 1982)