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510(k) K854615

MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES by Serono Diagnostics, Inc. — Product Code LKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1986
Date Received
November 18, 1985
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 Serono Diagnostics, Inc.

  • K953598 — SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS (March 11, 1996)
  • K942051 — SR1 DHEA-S ENZYME IMMUNOASSAY (July 13, 1994)
  • K883085 — T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS (September 9, 1988)
  • K882340 — LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA (August 8, 1988)
  • K880388 — T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE (March 3, 1988)
  • K874866 — T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE (February 11, 1988)
  • K873431 — PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH (October 20, 1987)
  • K873186 — LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA (September 29, 1987)
  • K873400 — PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA (September 25, 1987)
  • K872862 — PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS (September 18, 1987)

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)
  • K883776 — BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE (February 3, 1989)
  • K830342 — CULUTURE SET CHLAMYDIA ISOLATION AND (May 4, 1983)