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510(k) K781324

ALP TEST by Analytical & Research Chemicals, Inc. — Product Code CIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1978
Date Received
July 31, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
Device Class
Class II
Regulation Number
862.1050
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)
  • K781441 — BCG ALBUMIN REAGET (October 10, 1978)
  • K781306 — UREA NITROGEN TEST KIT (August 31, 1978)
  • K781308 — GLUCOLOUR (August 31, 1978)
  • K781309 — GOT PROCEDURE (August 31, 1978)
  • K781307 — GLUCOSE DETERM. KIT (August 31, 1978)
  • K781305 — UREA NITROGEN (August 31, 1978)

Other clearances for product code CIO

  • K880177 — ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT (April 5, 1988)
  • K860351 — ALKALINE PHOSPHATASE REAGENT SET (February 11, 1986)
  • K855192 — ALKALINE PHOSPHATASE REAGENT SET (January 14, 1986)
  • K844498 — SANDARE ALKALINE PHOSPHATASE PROCEDURE (December 10, 1984)
  • K844237 — ALKALINE PHOSPHATASE REAGENT SET (November 20, 1984)
  • K841064 — ALKALINE PHOSPHOTASE REAGENT SET (May 1, 1984)
  • K823578 — COBAS STANDARDS FOR CALCIUM-IN-ORGANIC (January 7, 1983)
  • K821200 — ALKALINE PHOSPHOTASE REAGENT SET (July 13, 1982)
  • K772257 — ALKALINE PHOSPHATASE TEST SET (December 22, 1977)
  • K770453 — PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE (May 3, 1977)