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510(k) K781441

BCG ALBUMIN REAGET by Analytical & Research Chemicals, Inc. — Product Code CIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1978
Date Received
August 21, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Green Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type

Other clearances by Analytical & Research Chemicals, Inc.

  • K823806 — DIRECT CREATININE PROCEDURE (January 14, 1983)
  • K823784 — ENZYMATIC CHOLESTEROL (COLORIMETRIC (January 14, 1983)
  • K823786 — ALKALINE PHOSPHATASE (January 14, 1983)
  • K781460 — CHLORIDE REAGENT (October 10, 1978)
  • K781309 — GOT PROCEDURE (August 31, 1978)
  • K781323 — LDH PROCEDURE (August 31, 1978)
  • K781308 — GLUCOLOUR (August 31, 1978)
  • K781306 — UREA NITROGEN TEST KIT (August 31, 1978)
  • K781307 — GLUCOSE DETERM. KIT (August 31, 1978)
  • K781324 — ALP TEST (August 31, 1978)

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