FDA 510(k), K120009, TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)

FDA 510(k), K120009, TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)

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510(K) Number: K120009
Device Name: TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)
Manufacturer: ABBOTT LABORATORIES
Device Classification Name: radioimmunoassay, testosterones and dihydrotestosterone
Regulation Number: 862.1680
Classification Product Code: CDZ
Date Received: 01/03/2012
Decision Date: 09/11/2012
Regulation Medical Specialty: Clinical Chemistry

Total pages: 2,990
Fully redacted pages: 2,018
Content pages: 972

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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