Atlas FDA

THYMUNE-T

FDA 510(k) clearance K780874 · decided 1978-06-14

Clearance details

K-number
K780874
Device name
THYMUNE-T
Applicant
Burroughs Wellcome Co.
Decision
Substantially Equivalent
Date received
1978-05-30
Decision date
1978-06-14
Days to decision
15 days
Clearance type
Traditional
Product code
DDC
Device class
2
Regulation number
866.5870
Medical specialty
Immunology
Advisory committee
Immunology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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

Recalls involving this device

No recalls on record reference this clearance.