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510(k) K820491

SGPT REAGENT SET by Anco Medical Reagents & Assoc. — Product Code CKD

K820491 is an FDA 510(k) premarket notification submitted by Anco Medical Reagents & Assoc. for the device "SGPT REAGENT SET". The FDA issued a decision of Substantially Equivalent on March 11, 1982. The device falls under product code CKD (Hydrazone Colorimetry, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Anco Medical Reagents & Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1982
Date Received
February 23, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hydrazone Colorimetry, Alt/Sgpt
Device Class
Class I
Regulation Number
862.1030
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)
  • K820500 — TOTAL LIPID REAGENT SET (March 11, 1982)
  • K820466 — SGOT REAGENT SET (March 11, 1982)
  • K812837 — ALKALINE PHOSPHATASE REAGENT SET (January 29, 1982)
  • K813415 — UREA NITROGEN REAGENT SET (December 31, 1981)

Other clearances for product code CKD

  • K991834 — CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 (September 9, 1999)
  • K941192 — ORTHO ALT MICROWELL TEST SYSTEM (May 16, 1995)
  • K896237 — COBAS READY ALT REAGENT (February 16, 1990)
  • K884784 — VIRGO(R) MICROWELL ALT ASSAY (December 29, 1988)
  • K883387 — ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) (October 13, 1988)
  • K864082 — REFLOTRON(R) ALT (GPT) (December 4, 1986)
  • K860485 — SGPT (ALT) REAGENT SET (COLORIMETRIC) (April 3, 1986)
  • K844283 — SGPT REAGENT SET (November 27, 1984)
  • K841059 — SGPT REAGENT SET (May 1, 1984)
  • K821207 — SGPT REAGENT SET (July 14, 1982)

FDA data resources