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510(k) K953066

SERODIA ATG by Fujirebio America, Inc. — Product Code DDC

K953066 is an FDA 510(k) premarket notification submitted by Fujirebio America, Inc. for the device "SERODIA ATG". The FDA issued a decision of Substantially Equivalent on August 14, 1995. The device falls under product code DDC (Thyroglobulin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5870. Fujirebio America, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1995
Date Received
June 30, 1995
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 Fujirebio America, Inc.

  • K905038 — OLYMPUS PK-TP ABSORBENT KIT (May 6, 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)
  • 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