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510(k) K881500

ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST by Ortho Diagnostic Systems, Inc. — Product Code LJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1988
Date Received
April 11, 1988
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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Other clearances for product code LJP

  • K063675 — DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT (September 24, 2007)
  • K941714 — CHLAMYDIA TRACHOMATIS ANTIGEN TEST (July 18, 1994)
  • K901243 — CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST (May 21, 1990)
  • K900870 — PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST (April 16, 1990)
  • K895839 — PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1 (February 1, 1990)
  • K883352 — FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI (October 6, 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)
  • K864128 — CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT (April 29, 1987)