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510(k) K033865

IDEIA PCE CHLAMYDIA by Dakocytomation, Ltd. — Product Code LJC

K033865 is an FDA 510(k) premarket notification submitted by Dakocytomation, Ltd. for the device "IDEIA PCE CHLAMYDIA". The FDA issued a decision of Substantially Equivalent on January 21, 2004. The device falls under product code LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)), a Class I device regulated under 21 CFR 866.3120.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2004
Date Received
December 12, 2003
Clearance Type
Special
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 for product code LJC

  • K032330 — CT OIA (March 2, 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)
  • K935807 — ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY (May 19, 1995)

FDA data resources