FDA 510(k) K182078, MiniCollect K2E K2EDTA Tubes, by Greiner Bio-One Na, Inc.

FDA 510(k) K182078, MiniCollect K2E K2EDTA Tubes, by Greiner Bio-One Na, Inc.

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Device Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number: K182078
Device Name: MiniCollect K2E K2EDTA Tubes
Applicant: Greiner Bio-One Na, Inc.
Regulation Number: 862.1675
Classification Product Code: JKA
Date Received: 08/02/2018
Decision Date: 01/25/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
510k Review Panel: Hematology

Total number of pages: 703
Fully redacted pages: 558
Content pages: 145

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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