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510(k) K940564

IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION by Dako Diagnostics , Ltd. — Product Code LJC

K940564 is an FDA 510(k) premarket notification submitted by Dako Diagnostics , Ltd. for the device "IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION". The FDA issued a decision of Substantially Equivalent on January 11, 1996. The device falls under product code LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)), a Class I device regulated under 21 CFR 866.3120. Dako Diagnostics , Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1996
Date Received
February 3, 1994
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 Dako Diagnostics , Ltd.

  • K981226 — IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VI (September 28, 1998)
  • K973954 — IMAGEN RESPIRATORY SCREEN (December 22, 1997)
  • K962037 — IMAGEN RESPIRATORY SCREEN (December 26, 1996)
  • K943557 — IMAGEN (January 9, 1995)
  • K932384 — IDEIA(TM) ROTAVIRUS (December 27, 1993)

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)
  • K951010 — CHLAMYDIA OIA (October 7, 1995)
  • K935807 — ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY (May 19, 1995)

FDA data resources