Strep D Fluor

FDA 510(k) K860041 · Bio Spec, Inc.

Substantially Equivalent

510(k) numberK860041

Submission

Device name
Strep D Fluor
Applicant
Bio Spec, Inc.
Concord, CA, US
Received
January 6, 1986
Decision date
January 24, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GTP – Exoenzymes, Multiple, Streptococcal
Device class
Class I (low risk)
Regulation
21 CFR 866.3720
Specialty
Microbiology

Other 510(k)s with product code GTP

510(k)DeviceApplicantDecision
K833738Leap Strep Test KitGTP · Traditional Cooper Biomedical, Inc.12/27/1983SE
K822799Streptacoccus Co-Agglutination KitGTP · Traditional American Scientific Products12/19/1982SE

More from American Scientific Products

510(k)DeviceDecision
K860091Bio Spec Gramafluor Test KitJTO · Traditional 01/21/1986SE
K841479Bio Spec Strep-A-Fluor Test KitJTO · Traditional 04/25/1984SE

Questions and answers

When was Strep D Fluor cleared by the FDA?

Strep D Fluor (K860041) received a 510(k) decision of Substantially Equivalent on January 24, 1986, 18 days after the submission was received.

What is the product code of K860041?

The FDA product code is GTP – Exoenzymes, Multiple, Streptococcal, a Class I (low risk) device regulated under 21 CFR 866.3720.