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510(k) K023592

SERAQUEST ANTI-THYROGLOBULIN by Quest Intl., Inc. — Product Code DDC

K023592 is an FDA 510(k) premarket notification submitted by Quest Intl., Inc. for the device "SERAQUEST ANTI-THYROGLOBULIN". The FDA issued a decision of Substantially Equivalent on January 6, 2003. The device falls under product code DDC (Thyroglobulin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5870. Quest Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2003
Date Received
October 25, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thyroglobulin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5870
Review Panel
IM
Submission Type

Other clearances by Quest Intl., Inc.

  • K091260 — SERAQUEST EBV EA-D IGG TEST (June 8, 2009)
  • K033915 — MODIFICATION TO SERAQUEST EB VCA IGG (January 16, 2004)
  • K033780 — MODIFICATION TO SERAQUEST VCA IGM (January 15, 2004)
  • K023593 — SERAQUEST ANTI-THYROID PEROXIDASE (TPO) (February 6, 2003)
  • K003069 — ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM (November 27, 2000)
  • K991975 — SERAQUEST EB NA IGG (November 2, 1999)
  • K990410 — SERAQUEST EB VCA IGG (October 28, 1999)
  • K990977 — SERAQUEST EB VAC IGM (October 6, 1999)
  • K982485 — SERAQUEST CMV IGM (January 13, 1999)
  • K982281 — SERAQUEST RUBELLA IGM (October 16, 1998)

Other clearances for product code DDC

  • K012208 — ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, (September 7, 2001)
  • K000363 — MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM (February 18, 2000)
  • K991610 — ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. (June 25, 1999)
  • K991179 — ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM (June 17, 1999)
  • K971835 — ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA (July 3, 1997)
  • K953066 — SERODIA ATG (August 14, 1995)
  • K943625 — AUTOSTAT II ANTI-THYROGLOBULIN (December 22, 1994)
  • K936010 — THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY (July 18, 1994)
  • K930486 — QUANTA LITE(TM) THYROID T ELISA (March 15, 1993)
  • K865020 — SERA-TEK THYROGLOBULIN ANTIBODY TEST (February 2, 1987)

FDA data resources