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510(k) K800673

SMAC REPLACEMENT REAGENTS/OF BUN-SERUM by Diagnostic Solutions, Inc. — Product Code CDW

K800673 is an FDA 510(k) premarket notification submitted by Diagnostic Solutions, Inc. for the device "SMAC REPLACEMENT REAGENTS/OF BUN-SERUM". The FDA issued a decision of Substantially Equivalent on May 28, 1980. The device falls under product code CDW (Diacetyl-Monoxime, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Diagnostic Solutions, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1980
Date Received
March 26, 1980
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 Diagnostic Solutions, Inc.

  • K934892 — RELIEF PLUS ONE REAGENT STRIP MODIFICATION (January 11, 1994)
  • K924398 — UNI-CHECK REAGENT STRIP (December 23, 1992)
  • K921825 — QUICK-CHECK II REAGENT STRIP (August 18, 1992)
  • K800689 — REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- (May 30, 1980)
  • K800681 — REAGENTS FOR DETERM. CO2 IN HUMAN SERUM (May 30, 1980)
  • K800677 — REAGENTS FOR DETERM. SERUM IRON IN HUMAN (May 28, 1980)
  • K800675 — REAGENTS FOR DETERM. TOTAL BILIRUBIN (May 28, 1980)
  • K800672 — SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC (May 28, 1980)
  • K800674 — SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER (May 28, 1980)
  • K800678 — REAGENTS FOR DETERM. ALBUMIN IN HUMAN (May 28, 1980)

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)

FDA data resources