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510(k) K900974

INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. by Stellar Bio Systems, Inc. — Product Code JRY

K900974 is an FDA 510(k) premarket notification submitted by Stellar Bio Systems, Inc. for the device "INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.". The FDA issued a decision of Substantially Equivalent on April 16, 1990. The device falls under product code JRY (Antiserum, Fluorescent, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Stellar Bio Systems, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1990
Date Received
March 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Epstein-Barr Virus
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

Other clearances by Stellar Bio Systems, Inc.

  • K992587 — EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM (December 22, 1999)
  • K990915 — INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY (April 21, 1999)
  • K990916 — INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY (April 21, 1999)
  • K914953 — IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY (February 19, 1992)
  • K905608 — INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 (November 7, 1991)
  • K882835 — INDIRECT FLUORESCENT ASSAY FOR (HCMV) (December 5, 1988)

Other clearances for product code JRY

  • K042118 — ATHENA MULTI-LYTE EBV IGG TEST SYSTEM (April 29, 2005)
  • K891785 — BION EBV-G (VCA) TEST SYSTEM (August 31, 1989)
  • K884829 — EBV EARLY ANTIGEN (R+D) (April 12, 1989)
  • K822734 — EBV IGM TEST (December 9, 1982)
  • K822985 — EBV-M KIT (December 3, 1982)
  • K821849 — EBV-VCA ANTIBODY ASSAY KIT (August 12, 1982)
  • K811262 — EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI (May 27, 1981)
  • K780925 — EB-VCA, TEST, ANTIBODY, FLUORESCENT (June 22, 1978)

FDA data resources