FDA 510K (K941007) CATALOG NO. J-ACT+ QC-ACT+

FDA 510K (K941007) CATALOG NO. J-ACT+ QC-ACT+

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Device Classification Name    Activated Whole Blood Clotting Time
510(k) Number    K941007
Device Name    CATALOG NO. J-ACT+ & QC-ACT+
Applicant     INTERNATIONAL TECHNIDYNE CORP.
Regulation Number    864.7140
Classification Product Code    JBP  
Date Received    03/01/1994
Decision Date    06/30/1994
Decision    Substantially Equivalent (SESE)
Regulation Medical Specialty    Hematology

Total pages: 177
Fully redacted pages: 102
Content pages: 75

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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