Home / 510(k) Clearances / K040708

510(k) K040708

STATUS FIRST STREP A by Princeton BioMeditech Corp. — Product Code GTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2004
Date Received
March 18, 2004
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 Princeton BioMeditech Corp.

  • K251538 — Status™ COVID-19/Flu A&B (November 14, 2025)
  • K182157 — BioSign Flu A+B (September 18, 2018)
  • K130650 — STATUS DS OXY (February 26, 2014)
  • K133474 — BIOSIGN FLU A + B, STATUS FLU A & B (December 10, 2013)
  • K132465 — BIOSIGN FLU A + B, STATUS FLU A & B (September 9, 2013)
  • K083746 — BIOSIGN FLU A+B (November 10, 2010)
  • K100817 — BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST (July 1, 2010)
  • K100341 — SPERMCHECK FERTILITY (May 4, 2010)
  • K082661 — BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A (October 6, 2008)
  • K073039 — SPERMCHECK VASECTOMY (January 24, 2008)

Other clearances for product code GTY

  • 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)
  • K051638 — INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC (December 6, 2005)