FDA 510(k) K972969, QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM, by Innovative Medical Technologies, Inc.

FDA 510(k) K972969, QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM, by Innovative Medical Technologies, Inc.

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Device Classification Name: Tube, Collection, Capillary Blood
510(k) Number: K972969
Device Name: QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM
Applicant: Innovative Medical Technologies, Inc.
Regulation Number: 864.6150
Classification Product Code: GIO
Date Received: 08/11/1997
Decision Date: 09/22/1997
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
510k Review Panel: Hematology

Total number of pages: 105
Fully redacted pages: 58
Content pages: 47

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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