Hygeia Rapid Strep a Test

FDA 510(k) K862133 · Hygeia Sciences

Substantially Equivalent

510(k) numberK862133

Submission

Device name
Hygeia Rapid Strep a Test
Applicant
Hygeia Sciences
Newton, MA, US
Received
June 4, 1986
Decision date
June 25, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GTY – Antigens, All Groups, Streptococcus Spp.
Device class
Class I (low risk)
Regulation
21 CFR 866.3740
Specialty
Microbiology

Other 510(k)s with product code GTY

510(k)DeviceApplicantDecision
K260342AllTest Strep A Rapid TestGTY · Traditional Hangzhou AllTest Biotech Co., Ltd.04/30/2026SE
K251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripGTY · Dual Track ACON Laboratories, Inc.11/26/2025SE
K212623Healgen Strep A Rapid Test Strip (Throat Swab)GTY · Traditional Healgen Scientific,, LLC03/16/2022SE
K171976Sofia Strep A+ FIA, Sofia 2 AnalyzerGTY · Dual Track Quidel Corporation12/21/2017SE
K141775Sofia (R) Strep A+ FiaGTY · Dual Track Quidel Corporation12/16/2014SE
K133343Wondfo Rapid Strep a TestGTY · Traditional Guangzhou Wondfo Biotech Co., Ltd.01/31/2014SE
K123793Sofia Strep a FiaGTY · Traditional Quidel Corporation06/17/2013SE
K122718BD Veritor(Tm) System for Rapid Detection of Group a StrepGTY · Traditional Becton, Dickinson and Company02/06/2013SE
K091489Clearview Advanced Strep a , Model 737-430GTY · Traditional Binax, Inc.09/04/2009SE
K082661Biostrep a, Biosign Strep a, Statusfirst Strep aGTY · Special Princeton BioMeditech Corp.10/06/2008SE

More from Princeton BioMeditech Corp.

510(k)DeviceDecision
K882192Hygeia Urine Pregnancy TestDHA · Traditional 11/10/1988SE
K881064Hygeia GC TestLIR · Traditional 06/02/1988SE
K862083Hygeia Sciences Urine HCG Flow Thorugh AssayJHJ · Traditional 07/02/1986SE

Questions and answers

When was Hygeia Rapid Strep a Test cleared by the FDA?

Hygeia Rapid Strep a Test (K862133) received a 510(k) decision of Substantially Equivalent on June 25, 1986, 21 days after the submission was received.

What is the product code of K862133?

The FDA product code is GTY – Antigens, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.