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510(k) K912666

DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 by Dako Corp. — Product Code LIQ

K912666 is an FDA 510(k) premarket notification submitted by Dako Corp. for the device "DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440". The FDA issued a decision of Substantially Equivalent on February 14, 1992. The device falls under product code LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus), a Class I device regulated under 21 CFR 866.3405. Dako Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1992
Date Received
June 18, 1991
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 Dako Corp.

  • K041627 — CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR (September 3, 2004)
  • K032692 — DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 (January 22, 2004)
  • K020023 — DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY (February 28, 2002)
  • K993957 — DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR (March 3, 2000)
  • K991454 — MOUSE IGG1 NEGATIVE CONTROLS (June 21, 1999)
  • K991402 — DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T (June 21, 1999)
  • K980635 — DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 (July 22, 1998)
  • K971905 — DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLON (December 12, 1997)
  • K965022 — MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMA (November 6, 1997)
  • K964974 — MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RP (June 24, 1997)

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