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510(k) K770470

WORTHINGTON BUN by Worthington Biochemical Corp. — Product Code CDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1977
Date Received
March 10, 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 Worthington Biochemical Corp.

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  • K772356 — LDH ISOENZYME COLUMN REAGENT SET (January 24, 1978)
  • K772025 — URIC ACID STD. FOR QUANT. URIC ACID (November 11, 1977)
  • K771001 — STATZYME GLUCOSE (July 11, 1977)
  • K771143 — INORGANIC PHOSPHORUS STANDARDS (July 11, 1977)
  • K770831 — STATZYME URIC ACID REAGENT (July 11, 1977)
  • K770277 — CHOLESTEROL STANDARDS (March 1, 1977)
  • K761262 — TRIGLYCERIDES (LIPASE) REAGENT SET (December 29, 1976)
  • K761263 — CHOLESTEROL AUTOMATED REAGENT (December 29, 1976)

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)