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510(k) K940564

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

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.

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  • 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)
  • K946276 — QUICKVUE(R) CHLAMYDIA TEST (May 19, 1995)