Home / 510(k) Clearances / K834443

510(k) K834443

ROTAVIRUS BIO-ENZABEAD SCREEN KIT by Litton Bionetics — Product Code LIQ

K834443 is an FDA 510(k) premarket notification submitted by Litton Bionetics for the device "ROTAVIRUS BIO-ENZABEAD SCREEN KIT". The FDA issued a decision of Substantially Equivalent on March 16, 1984. The device falls under product code LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus), a Class I device regulated under 21 CFR 866.3405. Litton Bionetics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1984
Date Received
December 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device Class
Class I
Regulation Number
866.3405
Review Panel
MI
Submission Type

Other clearances by Litton Bionetics

  • K840417 — EBNA ACIF KIT (December 27, 1984)
  • K831343 — CMV RQ BIO-ENZABEAD KIT (August 8, 1983)
  • K822985 — EBV-M KIT (December 3, 1982)
  • K821804 — RUBELLA RQ BIO-ENZABEAD KIT (September 14, 1982)
  • K801722 — CMV BIO-BEAD TITRATION KIT (September 16, 1980)
  • K801720 — TOXO BIO-BEAD TITRATION KIT (September 16, 1980)
  • K801721 — HSV BIO-BEAD TITRATION KIT (September 16, 1980)
  • K800789 — RUBELLA BIO-BEAD TITRATION KIT (June 30, 1980)
  • K791614 — HSV BIO-BEAD SCREEN KIT (November 13, 1979)
  • K791610 — RUBELLA BIO-BEAD SCREEN KIT (November 13, 1979)

Other clearances for product code LIQ

  • K990842 — SAS ROTA TEST (August 9, 1999)
  • K972895 — VIDAS ROTAVIRUS (RTV) ASSAY (October 3, 1997)
  • K971585 — IMMUNOCARD STAT! ROTAVIRUS (August 20, 1997)
  • K964424 — ROTAVIRUS EIA (August 8, 1997)
  • K965092 — VIDAS ROTAVIRUS ASSAY (May 5, 1997)
  • K951208 — ROTA-DAN RAPID ROTAVIRUS EIA KIT (February 14, 1996)
  • K942286 — DIARLEX ROTA-ADENO (December 14, 1994)
  • K933587 — IMMUNOCARD ROTAVIRUS (February 3, 1994)
  • K932384 — IDEIA(TM) ROTAVIRUS (December 27, 1993)
  • K915137 — KALLESTAD ROTAVIRUS MICROPLATE (March 4, 1992)

FDA data resources