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510(k) K872903

MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT. by Syva Co. — Product Code LJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1987
Date Received
July 27, 1987
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

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  • K900870 — PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST (April 16, 1990)
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  • K883352 — FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI (October 6, 1988)
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  • K880031 — PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS (March 17, 1988)
  • K872744 — MODIFIED CHLAMYSET ANTIGEN (September 22, 1987)
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