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510(k) K864811

ROTA-STAT by Intl. Diagnostic Laboratories, Ltd. — Product Code LIQ

K864811 is an FDA 510(k) premarket notification submitted by Intl. Diagnostic Laboratories, Ltd. for the device "ROTA-STAT". The FDA issued a decision of Substantially Equivalent on August 25, 1987. 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
August 25, 1987
Date Received
December 9, 1986
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.

  • K864228 — APO B., IMMUNOTURBIDIMETRIC ASSAY (March 12, 1987)
  • K864393 — APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC (January 16, 1987)
  • K843367 — ROTAVIRUS ENZYME IMMUNOASSAY (June 13, 1985)

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