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510(k) K852969

ROTACLONE ROTAVIRUS DIAGNOSTIC KIT by Cambridge Bioscience Corp. — Product Code LIQ

K852969 is an FDA 510(k) premarket notification submitted by Cambridge Bioscience Corp. for the device "ROTACLONE ROTAVIRUS DIAGNOSTIC KIT". The FDA issued a decision of Substantially Equivalent on November 5, 1985. The device falls under product code LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus), a Class I device regulated under 21 CFR 866.3405. Cambridge Bioscience Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1985
Date Received
July 15, 1985
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 Cambridge Bioscience Corp.

  • K890281 — HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES (March 15, 1989)
  • K881894 — ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) (July 8, 1988)
  • K873082 — ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST (February 24, 1988)
  • K873312 — ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST (February 24, 1988)

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