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510(k) K023592

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

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

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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)