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510(k) K943625

AUTOSTAT II ANTI-THYROGLOBULIN by Cogent Diagnotics , Ltd. — Product Code DDC

K943625 is an FDA 510(k) premarket notification submitted by Cogent Diagnotics , Ltd. for the device "AUTOSTAT II ANTI-THYROGLOBULIN". The FDA issued a decision of Substantially Equivalent on December 22, 1994. The device falls under product code DDC (Thyroglobulin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5870. Cogent Diagnotics , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1994
Date Received
July 26, 1994
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 Cogent Diagnotics , Ltd.

  • K003054 — AUTOSTAT II ENA-6 PROFILE ELISA (October 13, 2000)
  • K003057 — AUTOSTAT II ENA-4 PROFILE ELISA (October 13, 2000)
  • K002215 — AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA (September 28, 2000)
  • K993557 — AUTOSTAT II RHEUMATOID FACTOR IGA ELISA (March 3, 2000)
  • K994338 — AUTOSTAT II RHEUMATOID FACTOR IGM ELISA (February 3, 2000)
  • K993085 — AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA (February 1, 2000)
  • K993304 — AUTOSTAT II RHEUMATOID FACTOR IGG ELISA (December 6, 1999)
  • K992449 — AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA (November 24, 1999)
  • K993086 — AUTOSTAT II ANTI-GLIADIN IGA ELISA (November 12, 1999)
  • K993087 — AUTOSTAT II ANTI-GLIADIN IGG ELISA (November 12, 1999)

Other clearances for product code DDC

  • K023592 — SERAQUEST ANTI-THYROGLOBULIN (January 6, 2003)
  • 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)
  • 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