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510(k) K772257

ALKALINE PHOSPHATASE TEST SET by Stanbio Laboratory — Product Code CIO

K772257 is an FDA 510(k) premarket notification submitted by Stanbio Laboratory for the device "ALKALINE PHOSPHATASE TEST SET". The FDA issued a decision of Substantially Equivalent on December 22, 1977. The device falls under product code CIO (Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Stanbio Laboratory has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1977
Date Received
December 5, 1977
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 Stanbio Laboratory

  • K090093 — STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM (June 10, 2009)
  • K081719 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (July 18, 2008)
  • K050283 — CREATININE LIQUICOLOR (June 30, 2005)
  • K050266 — DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR (June 30, 2005)
  • K042169 — STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER (March 14, 2005)
  • K041155 — WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY (October 14, 2004)
  • K032936 — DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIB (March 12, 2004)
  • K032932 — DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR (March 10, 2004)
  • K032482 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (October 24, 2003)
  • K020378 — QUPID PLUS E.R. (June 21, 2002)

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)
  • K781324 — ALP TEST (August 31, 1978)
  • K770453 — PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE (May 3, 1977)

FDA data resources