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510(k) K833738

LEAP STREP TEST KIT by Cooper Biomedical, Inc. — Product Code GTP

K833738 is an FDA 510(k) premarket notification submitted by Cooper Biomedical, Inc. for the device "LEAP STREP TEST KIT". The FDA issued a decision of Substantially Equivalent on December 27, 1983. The device falls under product code GTP (Exoenzymes, Multiple, Streptococcal), a Class I device regulated under 21 CFR 866.3720. Cooper Biomedical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1983
Date Received
October 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exoenzymes, Multiple, Streptococcal
Device Class
Class I
Regulation Number
866.3720
Review Panel
MI
Submission Type

Other clearances by Cooper Biomedical, Inc.

  • K863868 — IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT (February 13, 1987)
  • K864512 — IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO (February 13, 1987)
  • K863301 — DEMAND TOTAL PROTEIN (September 26, 1986)
  • K861926 — WORTHINGTON HDL PRECIPITATING REAGENT SET (June 27, 1986)
  • K854130 — DEMAND ETHYL ALCOHOL (November 5, 1985)
  • K853949 — DEMAND ACID PHOSPHATASE REAGENT (October 16, 1985)
  • K852262 — ASSIST CLINICAL CHEMISTRY ANALYZER (June 25, 1985)
  • K851285 — RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI (June 17, 1985)
  • K851284 — RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM (June 11, 1985)
  • K851286 — RADIAL IMMUNODIFFUSION PLATES C3 & C4 (June 5, 1985)

Other clearances for product code GTP

  • K860041 — STREP D FLUOR (January 24, 1986)
  • K822799 — STREPTACOCCUS CO-AGGLUTINATION KIT (December 19, 1982)

FDA data resources