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510(k) K971835

ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA by Monobind — Product Code DDC

K971835 is an FDA 510(k) premarket notification submitted by Monobind for the device "ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA". The FDA issued a decision of Substantially Equivalent on July 3, 1997. The device falls under product code DDC (Thyroglobulin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5870. Monobind has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1997
Date Received
May 19, 1997
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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  • K063437 — ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 (April 4, 2008)
  • K030860 — ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 (August 22, 2003)
  • K020548 — FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 (April 5, 2002)
  • K980088 — T-UPTAKE MICROPLATE EIA (February 4, 1998)
  • K972720 — FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) (September 2, 1997)
  • K971834 — ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA (July 3, 1997)
  • K971921 — PROLACTIN (PRL) HORMONE MICROPLATE ELISA (June 24, 1997)
  • K971780 — THYROTROPIN(TSH) ELISA (June 24, 1997)
  • K971779 — TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA (June 16, 1997)

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)
  • 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