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510(k) K843367

ROTAVIRUS ENZYME IMMUNOASSAY by Intl. Diagnostic Laboratories, Ltd. — Product Code LIQ

K843367 is an FDA 510(k) premarket notification submitted by Intl. Diagnostic Laboratories, Ltd. for the device "ROTAVIRUS ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on June 13, 1985. The device falls under product code LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus), a Class I device regulated under 21 CFR 866.3405. Intl. Diagnostic Laboratories, Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1985
Date Received
August 28, 1984
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 Intl. Diagnostic Laboratories, Ltd.

  • K864811 — ROTA-STAT (August 25, 1987)
  • K864228 — APO B., IMMUNOTURBIDIMETRIC ASSAY (March 12, 1987)
  • K864393 — APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC (January 16, 1987)

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