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510(k) K851513

ULTRA-VIOLET BUN REAGENT KIT by Bio-Analytics Laboratories, Inc. — Product Code CDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1985
Date Received
April 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by Bio-Analytics Laboratories, Inc.

  • K861638 — KINETIC ALKALINE PHOSPHATASE REAGENT KIT (May 29, 1986)
  • K860245 — ENZYMATIC ALPHA-AMYLASE REAGENT KIT (March 14, 1986)
  • K860213 — ALBUMIN REAGENT KIT (February 11, 1986)
  • K851514 — ULTRA-VIOLET GLUCOSE REAGENT (May 20, 1985)
  • K850639 — ENZYMATIC ALPHA-AMYLASE REAGENT KIT (March 5, 1985)
  • K832771 — ERYTHROCYTE TEST (October 28, 1983)
  • K832567 — ACETAMINOPHEN(PARACETAMOL (September 12, 1983)
  • K831414 — COLORIMETRIC BUN (June 16, 1983)
  • K821934 — BIO-CAL OPERATION CHECK KIT (July 20, 1982)
  • K813431 — SALICYLATES (March 25, 1982)

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