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510(k) K880821

RESUBMITTED ABBOTT TESTPACK ROTAVIRUS by Abbott Laboratories — Product Code LIQ

K880821 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "RESUBMITTED ABBOTT TESTPACK ROTAVIRUS". The FDA issued a decision of Substantially Equivalent on May 6, 1988. The device falls under product code LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus), a Class I device regulated under 21 CFR 866.3405. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1988
Date Received
March 1, 1988
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

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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