Atlas FDA

DDC

13 FDA 510(k) clearances · Product code

45 daysmedian time to decision
149 days90th percentile
13clearances measured

FDA profile

Official device name
Thyroglobulin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5870
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
SERAQUEST ANTI-THYROGLOBULIN (K023592)Quest Intl., Inc.2003-01-06
ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 (K012208)Beckman Coulter, Inc.2001-09-07
MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM (K000363)Zeus Scientific, Inc.2000-02-18
ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. (K991610)Zeus Scientific, Inc.1999-06-25
ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM (K991179)Zeus Scientific, Inc.1999-06-17
ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA (K971835)Monobind1997-07-03
SERODIA ATG (K953066)Fujirebio America, Inc.1995-08-14
AUTOSTAT II ANTI-THYROGLOBULIN (K943625)Cogent Diagnotics , Ltd.1994-12-22
THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY (K936010)Biomerica, Inc.1994-07-18
QUANTA LITE(TM) THYROID T ELISA (K930486)Inova Diagnostics, Inc.1993-03-15
SERA-TEK THYROGLOBULIN ANTIBODY TEST (K865020)Miles Laboratories, Inc.1987-02-02
THYMUNE-M (K780873)Burroughs Wellcome Co.1978-06-14
THYMUNE-T (K780874)Burroughs Wellcome Co.1978-06-14

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Every clearance here is in the API, with alerts when new ones post.