Home / 510(k) Clearances / K853695

510(k) K853695

RESPIRATORY SYNCYTIAL VIRUS ID REAGENT by Viromed Laboratories, Inc. — Product Code GQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1985
Date Received
September 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Device Class
Class I
Regulation Number
866.3480
Review Panel
MI
Submission Type

Other clearances by Viromed Laboratories, Inc.

  • K951461 — NCI-H292 CELL CULTURE (May 22, 1996)
  • K951440 — LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE (May 22, 1996)
  • K871613 — BUFFALO GREEN MONKEY KIDNEY CELLS (May 13, 1987)
  • K862555 — HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA) (July 10, 1986)
  • K861373 — HUMAN LUNG CARCINOMA CELLS (A549) (April 18, 1986)
  • K852395 — MINK LUNG (July 12, 1985)
  • K852396 — HEK (July 12, 1985)
  • K852394 — MDCK (July 12, 1985)
  • K843251 — RD CELLS (September 6, 1984)
  • K843250 — BHK-21 (September 6, 1984)

Other clearances for product code GQG

  • K253318 — Clungene RSV Antigen Rapid Test (January 30, 2026)
  • K240280 — Nano-Check™ RSV Test (July 30, 2024)
  • K162911 — Sofia RSV FIA on Sofia 2 analyzer (February 22, 2017)
  • K133140 — BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV (November 15, 2013)
  • K132456 — BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV (November 7, 2013)
  • K130398 — SOFIA(R) RSV FIA (August 13, 2013)
  • K121633 — BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV (September 18, 2012)
  • K101918 — QUICKVUE RSV 10 (September 24, 2010)
  • K101514 — BD DIRECTIGEN EZ RSV (July 9, 2010)
  • K091235 — RAMP RSV ASSAY (July 24, 2009)