Home / 510(k) Clearances / K864389

510(k) K864389

CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST by American Micro Scan — Product Code LJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1986
Date Received
November 6, 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 American Micro Scan

  • K864662 — CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS (March 25, 1987)
  • K870029 — IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE (March 25, 1987)
  • K863776 — MICRODILUTION MIC PANELS (February 2, 1987)
  • K864674 — MICRODILUTION IDENTIFICATION PANELS (January 5, 1987)
  • K863038 — GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL (September 30, 1986)
  • K862642 — GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL (September 11, 1986)
  • K862332 — ANAEROBE RAPID CHROMOGENIC ID PANEL (August 27, 1986)
  • K862140 — MICRODILUTION PANELS (July 16, 1986)
  • K861584 — GRAM NEGATIVE COMBO PANEL TYPE 3 (June 17, 1986)
  • K860575 — YEAST IDENTIFICATION PANEL (May 13, 1986)

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)
  • 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)