Product code DDC— Immunology
ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895
- Classification name
- Thyroglobulin, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5870
- Advisory panel
- Immunology
- Total cleared
- 13
- First cleared
- Most recent
Market context for product code DDC
FDA has cleared devices under product code DDC between 1978 and 2003, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2003
- 2001
- 2000
- 1999
- 1997
- 1995
- 1994
- 1993
- 1987
- 1978
Top applicants under product code DDC
Recent clearances under product code DDC
- K023592 — SERAQUEST ANTI-THYROGLOBULIN
- K012208 — ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895
- K000363 — MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
- K991610 — ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.
- K991179 — ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
- K971835 — ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA
- K953066 — SERODIA ATG
- K943625 — AUTOSTAT II ANTI-THYROGLOBULIN
- K936010 — THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY
- K930486 — QUANTA LITE(TM) THYROID T ELISA
- K865020 — SERA-TEK THYROGLOBULIN ANTIBODY TEST
- K780873 — THYMUNE-M
- K780874 — THYMUNE-T
Data sourced from openFDA. This site is unofficial and independent of the FDA.