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510(k) K822323

ULTRACHEM BUN-UV, 65080 & 65081 by Harleco Diagnostics — Product Code CDW

K822323 is an FDA 510(k) premarket notification submitted by Harleco Diagnostics for the device "ULTRACHEM BUN-UV, 65080 & 65081". The FDA issued a decision of Substantially Equivalent on September 2, 1982. The device falls under product code CDW (Diacetyl-Monoxime, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Harleco Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1982
Date Received
August 3, 1982
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 Harleco Diagnostics

  • K823147 — URIC ACID STANDARD, 8MG/DL #65078 (November 22, 1982)
  • K822852 — TRIGLYCERIDE CALIBRATOR (October 27, 1982)
  • K821880 — ULTRA CHEM ALB (July 14, 1982)
  • K821877 — ULTRAZYME PLUS HBD (July 14, 1982)
  • K821871 — ULTRAZYME PLUS 2GT (July 14, 1982)
  • K821883 — ULTRAZYME PLUS CK-I (July 14, 1982)
  • K821879 — ULTRACHEM T.P. (July 14, 1982)
  • K821882 — ULTRAZYME PLUS GPT (July 14, 1982)
  • K821878 — ULTRAZYME PLUS LDH (July 14, 1982)
  • K821872 — ULTRACHEM URIC ACID AIDH (July 14, 1982)

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)
  • K821212 — UREA NITROGEN REAGENT SET (July 22, 1982)
  • K813415 — UREA NITROGEN REAGENT SET (December 31, 1981)

FDA data resources