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510(k) K905531

LUPUS(LE)-LATEX TEST by Immco Diagnostics, Inc. — Product Code LKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1991
Date Received
December 10, 1990
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

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Other clearances for product code LKI

  • K914953 — IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY (February 19, 1992)
  • 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)