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510(k) K936010

THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY by Biomerica, Inc. — Product Code DDC

K936010 is an FDA 510(k) premarket notification submitted by Biomerica, Inc. for the device "THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on July 18, 1994. The device falls under product code DDC (Thyroglobulin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5870. Biomerica, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1994
Date Received
December 16, 1993
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 Biomerica, Inc.

  • K232892 — Hp Detect™ Stool Antigen ELISA (December 15, 2023)
  • K003856 — EZ-HCG URINE(PREGNANCY TEST) (February 21, 2001)
  • K982954 — FREE T4 MICROWELL EIA, MODEL #7019 (September 24, 1998)
  • K962216 — TSH (MICROWELL) ELISA (September 19, 1996)
  • K960412 — T-3 MICROWELL EIA MODEL 7013 (March 19, 1996)
  • K954256 — ANTI-TPO (November 27, 1995)
  • K950588 — T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 (June 29, 1995)
  • K915185 — GAP IGG H.PYLORI MODIFIED (March 4, 1992)
  • K900343 — GAP-IGG (August 22, 1991)

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)
  • K943625 — AUTOSTAT II ANTI-THYROGLOBULIN (December 22, 1994)
  • K930486 — QUANTA LITE(TM) THYROID T ELISA (March 15, 1993)
  • K865020 — SERA-TEK THYROGLOBULIN ANTIBODY TEST (February 2, 1987)

FDA data resources