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510(k) K032330

CT OIA by Thermo Biostar, Inc. — Product Code LJC

K032330 is an FDA 510(k) premarket notification submitted by Thermo Biostar, Inc. for the device "CT OIA". The FDA issued a decision of Substantially Equivalent on March 2, 2004. The device falls under product code LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)), a Class I device regulated under 21 CFR 866.3120. Thermo Biostar, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2004
Date Received
July 29, 2003
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 Thermo Biostar, Inc.

  • K023947 — GC OIA (April 17, 2003)
  • K023556 — FLU OIA A/B TEST KIT (March 27, 2003)
  • K023779 — RSV OIA (January 14, 2003)
  • K021172 — RSV OIA (September 13, 2002)

Other clearances for product code LJC

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

FDA data resources