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510(k) K894625

CHLAMYDIA (LGV-1) by Bion Ent., Ltd. — Product Code LKI

K894625 is an FDA 510(k) premarket notification submitted by Bion Ent., Ltd. for the device "CHLAMYDIA (LGV-1)". The FDA issued a decision of Substantially Equivalent on August 15, 1989. The device falls under product code LKI (Antisera, Fluorescent, Chlamydia Spp.), a Class I device regulated under 21 CFR 866.3120. Bion Ent., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1989
Date Received
July 20, 1989
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 Bion Ent., Ltd.

  • K926066 — BION MUMPS-G ANTIBODY TEST SYSTEM (June 15, 1993)
  • K901054 — BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE (April 5, 1990)
  • K894622 — VARICELLA ZOSTER VIRUS (October 24, 1989)
  • K894623 — RESPIRATORY SYNCYTIAL VIRUS (October 16, 1989)
  • K894626 — EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN (October 16, 1989)
  • K894624 — MUMPS VIRUS (October 16, 1989)
  • K891785 — BION EBV-G (VCA) TEST SYSTEM (August 31, 1989)
  • K893240 — BION EBV-M (VCA) TEST SYSTEM (July 14, 1989)
  • K890616 — BION DIRECT IDENTIFICATION CONTROL SLIDE (February 17, 1989)
  • K881261 — BION HSV1-G OR HSV2-G TEST SYSTEM (June 7, 1988)

Other clearances for product code LKI

  • K914953 — IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY (February 19, 1992)
  • K905531 — LUPUS(LE)-LATEX TEST (January 25, 1991)
  • 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)

FDA data resources