Home / 510(k) Clearances / K862133

510(k) K862133

HYGEIA RAPID STREP A TEST by Hygeia Sciences — Product Code GTY

K862133 is an FDA 510(k) premarket notification submitted by Hygeia Sciences for the device "HYGEIA RAPID STREP A TEST". The FDA issued a decision of Substantially Equivalent on June 25, 1986. The device falls under product code GTY (Antigens, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Hygeia Sciences has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1986
Date Received
June 4, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Hygeia Sciences

  • K882192 — HYGEIA URINE PREGNANCY TEST (November 10, 1988)
  • K881064 — HYGEIA GC TEST (June 2, 1988)
  • K862083 — HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY (July 2, 1986)

Other clearances for product code GTY

  • K260342 — AllTest Strep A Rapid Test (April 30, 2026)
  • K251697 — Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test St (November 26, 2025)
  • K212623 — Healgen Strep A Rapid Test Strip (Throat Swab) (March 16, 2022)
  • K171976 — Sofia Strep A+ FIA, Sofia 2 Analyzer (December 21, 2017)
  • K141775 — SOFIA (R) STREP A+ FIA (December 16, 2014)
  • K133343 — WONDFO RAPID STREP A TEST (January 31, 2014)
  • K123793 — SOFIA STREP A FIA (June 17, 2013)
  • K122718 — BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP (February 6, 2013)
  • K091489 — CLEARVIEW ADVANCED STREP A , MODEL 737-430 (September 4, 2009)
  • K082661 — BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A (October 6, 2008)

FDA data resources