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510(k) K883776

BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE by Btc Corp. — Product Code LKI

K883776 is an FDA 510(k) premarket notification submitted by Btc Corp. for the device "BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE". The FDA issued a decision of Substantially Equivalent on February 3, 1989. The device falls under product code LKI (Antisera, Fluorescent, Chlamydia Spp.), a Class I device regulated under 21 CFR 866.3120.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1989
Date Received
September 6, 1988
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 for product code LKI

  • K914953 — IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY (February 19, 1992)
  • K905531 — LUPUS(LE)-LATEX TEST (January 25, 1991)
  • K894625 — CHLAMYDIA (LGV-1) (August 15, 1989)
  • K854615 — MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES (January 28, 1986)
  • K830342 — CULUTURE SET CHLAMYDIA ISOLATION AND (May 4, 1983)

FDA data resources