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510(k) K951208

ROTA-DAN RAPID ROTAVIRUS EIA KIT by Eldan Technologies, Ltd. — Product Code LIQ

K951208 is an FDA 510(k) premarket notification submitted by Eldan Technologies, Ltd. for the device "ROTA-DAN RAPID ROTAVIRUS EIA KIT". The FDA issued a decision of Substantially Equivalent on February 14, 1996. The device falls under product code LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus), a Class I device regulated under 21 CFR 866.3405.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1996
Date Received
March 17, 1995
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 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)
  • 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)
  • K912666 — DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 (February 14, 1992)

FDA data resources