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510(k) K865053

Device
SERA-TEK MICROSOMAL ANTIBODY TEST
Applicant
MILES LABORATORIES, INC.
510(k) number
K865053
Product code
JZO  
Decision
Substantially Equivalent (SESE)
Decision date
1987-02-18
Date received
1986-12-24
Regulation
866.5870
Classification name
System, Test, Thyroid Autoantibody
Medical specialty
Immunology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN H ENGELMANN
Address
1127 Myrtle St. P.O. Box 40 Elkhart IN US 46514 46514

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JZO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250250ADVIA Centaur Anti-Thyroid Peroxidase IISiemens Healthcare Diagnostics, Inc.2025-10-17
K240469Access TPO AntibodyBeckman Coulter, Inc.2024-08-09
K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc.2023-09-26
K222610Elecsys Anti-TgRoche Diagnostics2023-09-15
K193313Elecsys Anti-TSHRRoche Diagnostics2020-02-27
K151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000Phadia AB2016-03-25
K152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.2016-03-03
K092229THYRETAIN TM TSI REPORTER BIOASSAYDiagnostic Hybrids, Inc.2010-05-18
K090760THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120Theratest Laboratories, Inc.2009-09-03
K083391THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAYDiagnostic Hybrids, Inc.2009-05-21
K080092ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROABRoche Diagnostics Corp.2008-07-28
K080159KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KITKronus Market Development Associates, Inc.2008-05-22
K061794FIDIS TM THYRO, MODEL MX002Biomedical Diagnostics (Bmd) SA2006-11-21
K052407ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLSFisher Diagnostics2006-07-18
K061382ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227Beckman Coulter, Inc.2006-07-06

Legacy Summary#

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FDA Review#

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