Home / 510(k) Clearances / K812013

510(k) K812013

FLUORESCENT ANTIBODY CONJUGATE FOR GP.A by Springwood Microbiologicals — Product Code GTX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1981
Date Received
July 17, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, All Groups, Streptococcus Spp.
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

Other clearances by Springwood Microbiologicals

  • K813339 — DIRECT FA CONJUGATE FOR LEGIONELLA SP (December 18, 1981)

Other clearances for product code GTX

  • K801876 — STREP B POLYVALENT FLUORO-KIT (September 16, 1980)