• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K080092, ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB, by Roche Diagnostics Corp.

FDA 510(k) K080092, ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB, by Roche Diagnostics Corp.

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510(K) Number: K080092
Device Name: ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
Manufacturer:     ROCHE DIAGNOSTICS CORP.
Device Classification Name: System, Test, Thyroid Autoantibody
Regulation Number: 866.5870
Classification Product Code: JZO
Date Received: 01/14/2008
Decision Date: 07/28/2008
Regulation Medical Specialty: Immunology

Total pages: 447
Fully redacted pages: 140
Content pages: 307
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