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510(k) K942173

RSV ANTIGEN TEST by Neogenex — Product Code LKT

K942173 is an FDA 510(k) premarket notification submitted by Neogenex for the device "RSV ANTIGEN TEST". The FDA issued a decision of Substantially Equivalent on June 30, 1994. The device falls under product code LKT (Respiratory Syncytial Virus, Antigen, Antibody, Ifa), a Class I device regulated under 21 CFR 866.3480. Neogenex has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1994
Date Received
May 5, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Device Class
Class I
Regulation Number
866.3480
Review Panel
MI
Submission Type

Other clearances by Neogenex

  • K965047 — MINK LUNG CELL CULTURE (February 4, 1997)
  • K960909 — H292 CELL CULTURE (May 30, 1996)
  • K943885 — PRIMARY RABBIT KIDNEY CELL CULTURE (November 28, 1994)
  • K943890 — WI38 CELL CULTURE (November 28, 1994)
  • K943884 — PRIMARY MONKEY KIDNEY CELL CULTURE (November 28, 1994)
  • K943888 — MDCK CELL CULTURE (November 28, 1994)
  • K943887 — HUMAN NEWBORN FORESKIN CELL CULTURE (November 28, 1994)
  • K943891 — RD CULTURE CELL (November 28, 1994)
  • K943889 — VERO CELL CULTURE (November 28, 1994)
  • K943886 — BGM CELL CULTURE (November 28, 1994)

Other clearances for product code LKT

  • K081928 — D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT (December 23, 2008)
  • K983336 — PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 (March 18, 1999)
  • K943317 — PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV) (December 19, 1994)
  • K912842 — RSV-MAB TEST (December 9, 1991)
  • K912838 — BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO (September 27, 1991)
  • K912371 — BIOMERIEUX RSV DIRECT IF KIT (September 23, 1991)
  • K894623 — RESPIRATORY SYNCYTIAL VIRUS (October 16, 1989)
  • K884192 — RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION (November 22, 1988)
  • K882687 — ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST (August 30, 1988)
  • K873564 — GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES (November 20, 1987)

FDA data resources