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510(k) K951010

CHLAMYDIA OIA by Biostar, Inc. — Product Code LJC

K951010 is an FDA 510(k) premarket notification submitted by Biostar, Inc. for the device "CHLAMYDIA OIA". The FDA issued a decision of Substantially Equivalent on October 7, 1995. The device falls under product code LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)), a Class I device regulated under 21 CFR 866.3120. Biostar, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1995
Date Received
March 6, 1995
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 Biostar, Inc.

  • K991829 — CDTOX A OIA (November 2, 1999)
  • K991828 — STREP B OIA (August 19, 1999)
  • K981651 — AB FLU OIA (November 25, 1998)
  • K962060 — STREP A OIA MAX (July 23, 1997)
  • K936112 — STREP B OIA (July 6, 1994)

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

FDA data resources