SGOT REAGENT SET— 510(k) K820466

Clearance details

Applicant

Anco Medical Reagents & Assoc.

Product code

Code CIQ

Device class

Class 2

Regulation

21 CFR 862.1100

Advisory panel

Clinical Chemistry

Date received

1982-02-22

Decision date

1982-03-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

• K881173 — ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)1988-06-07
• K860216 — SGOT (AST) REAGENT SET1986-04-03
• K855189 — GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET1986-01-14
• K844322 — SGOT REAGENT SET1984-11-27
• K841065 — SGOT REAGENT SET1984-05-01

• K842440 — SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH1984-07-27
• K831871 — SICKLE-HEME A/S CONTROLS & A/A CONTROL1983-07-28
• K821658 — HEMOGLOBIN REAGENT1982-06-25
• K821526 — ACID PHOSPHATASE REAGENT SET1982-06-10
• K821102 — MEGNESIUM REAGENT KIT1982-05-05