Atlas FDA

DIASTAT ANTI-THYROGLOBULIN KIT

FDA 510(k) clearance K952183 · decided 1995-06-30

Clearance details

K-number
K952183
Device name
DIASTAT ANTI-THYROGLOBULIN KIT
Applicant
Shield Diagnostics, Ltd.
Decision
Substantially Equivalent
Date received
1995-05-09
Decision date
1995-06-30
Days to decision
52 days
Clearance type
Traditional
Product code
JZO
Device class
2
Regulation number
866.5870
Medical specialty
Immunology
Advisory committee
Immunology
Location
Dundee, GB
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Shield Diagnostics

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
ADVIA Centaur Anti-Thyroid Peroxidase II (K250250)Siemens Healthcare Diagnostics, Inc.2025-10-17
Access TPO Antibody (K240469)Beckman Coulter, Inc.2024-08-09
Access Thyroglobulin Antibody II (K213517)Beckman Coulter, Inc.2023-09-26
Elecsys Anti-Tg (K222610)Roche Diagnostics2023-09-15
Elecsys Anti-TSHR (K193313)Roche Diagnostics2020-02-27
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 (K151799)Phadia AB2016-03-25
IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material (K152061)Siemens Healthcare Diagnostics, Inc.2016-03-03
THYRETAIN TM TSI REPORTER BIOASSAY (K092229)Diagnostic Hybrids, Inc.2010-05-18
THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 (K090760)Theratest Laboratories, Inc.2009-09-03
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY (K083391)Diagnostic Hybrids, Inc.2009-05-21
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB (K080092)Roche Diagnostics Corp.2008-07-28
KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT (K080159)Kronus Market Development Associates, Inc.2008-05-22

Recalls involving this device

RecordFirmDate
Data reduction program software written specifically for Bio-Tek ELx800 (DiaSorin part # 1 recall (Z-0675-05)Diasorin Inc.2005-04-06