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510(k) K914953

IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY by Stellar Bio Systems, Inc. — Product Code LKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1992
Date Received
November 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Chlamydia Spp.
Device Class
Class I
Regulation Number
866.3120
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)
  • K990916 — INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY (April 21, 1999)
  • K990915 — INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY (April 21, 1999)
  • K905608 — INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 (November 7, 1991)
  • K900974 — INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. (April 16, 1990)
  • K882835 — INDIRECT FLUORESCENT ASSAY FOR (HCMV) (December 5, 1988)

Other clearances for product code LKI

  • K905531 — LUPUS(LE)-LATEX TEST (January 25, 1991)
  • K894625 — CHLAMYDIA (LGV-1) (August 15, 1989)
  • K883776 — BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE (February 3, 1989)
  • K854615 — MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES (January 28, 1986)
  • K830342 — CULUTURE SET CHLAMYDIA ISOLATION AND (May 4, 1983)