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510(k) K843120

APPLELISA CHLAMYDIA TRACHOMATIS ANTI by Apple Diagnostic Products — Product Code LJC

K843120 is an FDA 510(k) premarket notification submitted by Apple Diagnostic Products for the device "APPLELISA CHLAMYDIA TRACHOMATIS ANTI". The FDA issued a decision of Substantially Equivalent on September 12, 1984. The device falls under product code LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)), a Class I device regulated under 21 CFR 866.3120. Apple Diagnostic Products has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1984
Date Received
August 8, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Device Class
Class I
Regulation Number
866.3120
Review Panel
MI
Submission Type

Other clearances by Apple Diagnostic Products

  • K844287 — ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII (January 7, 1985)
  • K843745 — ADP ANA APPLEZYME (October 25, 1984)
  • K842707 — ADP NDNA IFA TEST (August 21, 1984)
  • K842183 — ADP ANA IFA TEST (June 22, 1984)
  • K834241 — ANA APPLELISA (April 4, 1984)
  • K834242 — ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS (March 2, 1984)

Other clearances for product code LJC

  • K032330 — CT OIA (March 2, 2004)
  • K033865 — IDEIA PCE CHLAMYDIA (January 21, 2004)
  • K033079 — CHLAMYDIA IGG ELISA TEST SYSTEM (November 26, 2003)
  • K982210 — MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA (July 9, 1998)
  • K962558 — CHLAMYDIA IGG ELISA TEST SYSTEM (February 24, 1997)
  • K960850 — ACCESS CHLAMYDIA ASSAY (February 4, 1997)
  • K955627 — VIDAS CHLAMYDIA BLOCKING ASSAY (October 7, 1996)
  • K936054 — IMX SELECT CHLAMYDIA (May 30, 1996)
  • K940564 — IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION (January 11, 1996)
  • K951010 — CHLAMYDIA OIA (October 7, 1995)

FDA data resources