Home / 510(k) Clearances / K946276

510(k) K946276

QUICKVUE(R) CHLAMYDIA TEST by Quidel Corp. — Product Code LJC

K946276 is an FDA 510(k) premarket notification submitted by Quidel Corp. for the device "QUICKVUE(R) CHLAMYDIA TEST". The FDA issued a decision of Substantially Equivalent on May 19, 1995. The device falls under product code LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)), a Class I device regulated under 21 CFR 866.3120. Quidel Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1995
Date Received
December 23, 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 Quidel Corp.

  • K131813 — QUIDEL MOLECULAR RSV + HMPV ASSAY (September 6, 2013)
  • K131728 — QUIDEL MOLECULAR INFLUENZA A + B ASSAY (August 29, 2013)
  • K130398 — SOFIA(R) RSV FIA (August 13, 2013)
  • K131166 — SOFIA(R) HCG FIA (August 2, 2013)
  • K131606 — SOFIA INFLUENZA A+B FIA (July 5, 2013)
  • K131619 — QUICKVUE INFLUENZA A+B (June 28, 2013)
  • K122189 — QUIDEL MOLECULAR RSV + HMPV ASSAY (March 8, 2013)
  • K123998 — QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY (March 8, 2013)
  • K113777 — QUIDEL MOLECULAR INFLUENZA A+B (March 15, 2012)
  • K112172 — QUIDEL MOLECULAR INFLUENZA A + B ASSAY (December 22, 2011)

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)
  • K951010 — CHLAMYDIA OIA (October 7, 1995)

FDA data resources