LEAP STREP TEST KIT— 510(k) K833738

Substantially Equivalent

Cooper Biomedical, Inc.

FDA 510(k) clearance K833738 for LEAP STREP TEST KIT, Substantially Equivalent on 1983-12-27. Applicant: Cooper Biomedical, Inc.. Device class: 1.

Clearance details

Applicant: Cooper Biomedical, Inc.
Product code: Code GTP
Device class: Class 1
Regulation: 21 CFR 866.3720
Advisory panel: Microbiology
Date received: 1983-10-25
Decision date: 1983-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GTP

K860041 — STREP D FLUOR1986-01-24
K822799 — STREPTACOCCUS CO-AGGLUTINATION KIT1982-12-19

More clearances from Cooper Biomedical, Inc.

K863868 — IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT1987-02-13
K864512 — IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO1987-02-13
K863301 — DEMAND TOTAL PROTEIN1986-09-26
K861926 — WORTHINGTON HDL PRECIPITATING REAGENT SET1986-06-27
K854130 — DEMAND ETHYL ALCOHOL1985-11-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.