Atlas FDA

CEE

25 FDA 510(k) clearances · Product code

43 daysmedian time to decision
96 days90th percentile
25clearances measured

FDA profile

Official device name
Radioimmunoassay, Thyroxine-Binding Globulin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1685
Medical specialty
Clinical Chemistry
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RecordFirmDate
AMERLITE TBG ASSAY (K952284)Johnson & Johnson Clinical Diagnostics, Inc.1995-07-26
ACCESS THYROID UPTAKE ASSAY (K930010)Bio-Rad Laboratories, Inc.1993-06-07
IMMULITE(TM) T-UPTAKE (K910677)Cirrus Diagnostics, Inc.1991-04-29
MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT (K905777)Immunotech Corp.1991-01-30
DELFIA TBG KIT (K900240)Pharmacia, Inc.1990-03-30
ENZYMUN TEST(R) TBK (K896991)Boehringer Mannheim Corp.1990-03-01
AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT (K893469)Amersham Corp.1989-08-15
T-UPTAKE MICROASSAY (K885034)Diamedix Corp.1989-02-02
FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT (K884201)Cyberfluor, Inc.1988-12-14
TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) (K874658)Technicon Instruments Corp.1987-12-18
ENZYMUN TEST TBG (K862109)Boehringer Mannheim Corp.1986-06-30
TIPSEP-TBG ASSAY (K861735)Nuclear Diagnostics, Inc.1986-06-13
TBG RIA (K842167)Syncor Intl. Corp.1984-07-09
THYROXINE-BINDING GLOBULIN RADIOUMMU (K842010)Nichols Institute Diagnostics1984-06-25
VENTREZYME T4U IMMUNOASSAY T4U (K841024)Ventrex Laboratories, Inc.1984-05-09
ENDAB THYROID UPTAKE (K822684)Immunotech Corp.1982-10-08
TBG DIAGNOSTIC KIT (K820252)Diagnostic Reagents, Inc.1982-05-05
IN-VITRO TBG RADIOIMMUNOASSAY TEST (K810967)Clinical Assays, Inc.1981-04-23
RIA PHASE TBG (K800204)Boehringer Mannheim Corp.1980-03-19
GLOBULIN TEST, HUMAN THYROXINE BINDING (K781225)Hyland Therapeutic Div., Travenol Laboratories1978-08-31
125 I-T3 UPTAKE REAGENT (K780671)Radioimmunoassay, Inc.1978-06-06
STIKSEP-T3 KIT (K780486)Nuclear Diagnostics, Inc.1978-04-28
THYROID BINDING GLOBULIN (K772183)Corning Medical & Scientific1977-12-20
SPINSEP-TBG (K771341)Nuclear Diagnostics, Inc.1977-08-10
PROCEDURE, RA, THYROXINE BINDING PROTEIN (K760134)Bio-Rad1976-07-20

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