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510(k) K862354

MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT by Synbiotics Corp. — Product Code LJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1986
Date Received
June 20, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Chlamydia Trachomatis
Device Class
Class I
Regulation Number
866.3120
Review Panel
MI
Submission Type

Other clearances by Synbiotics Corp.

  • K883235 — RAPIDTEST-HCG (TM) (September 30, 1988)
  • K873784 — NOVA STREP A (November 12, 1987)

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  • K895839 — PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1 (February 1, 1990)
  • K883352 — FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI (October 6, 1988)
  • K881500 — ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST (April 27, 1988)
  • K880031 — PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS (March 17, 1988)
  • K872744 — MODIFIED CHLAMYSET ANTIGEN (September 22, 1987)
  • K872903 — MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT. (August 6, 1987)