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510(k) K812837

ALKALINE PHOSPHATASE REAGENT SET by Anco Medical Reagents & Assoc. — Product Code CJL

K812837 is an FDA 510(k) premarket notification submitted by Anco Medical Reagents & Assoc. for the device "ALKALINE PHOSPHATASE REAGENT SET". The FDA issued a decision of Substantially Equivalent on January 29, 1982. The device falls under product code CJL (Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Anco Medical Reagents & Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1982
Date Received
October 9, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes
Device Class
Class II
Regulation Number
862.1050
Review Panel
CH
Submission Type

Other clearances by Anco Medical Reagents & Assoc.

  • K842440 — SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH (July 27, 1984)
  • K831871 — SICKLE-HEME A/S CONTROLS & A/A CONTROL (July 28, 1983)
  • K821658 — HEMOGLOBIN REAGENT (June 25, 1982)
  • K821526 — ACID PHOSPHATASE REAGENT SET (June 10, 1982)
  • K821102 — MEGNESIUM REAGENT KIT (May 5, 1982)
  • K820951 — ENZYMATIC CHOLESTEROL KIT (April 26, 1982)
  • K820466 — SGOT REAGENT SET (March 11, 1982)
  • K820491 — SGPT REAGENT SET (March 11, 1982)
  • K820500 — TOTAL LIPID REAGENT SET (March 11, 1982)
  • K813415 — UREA NITROGEN REAGENT SET (December 31, 1981)

FDA data resources