FDA 510(k) K063357, MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES, by Greiner Bio-One North America, Inc.
FDA 510(k) K063357, MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES, by Greiner Bio-One North America, Inc.
FDA 510(k) records for MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES (K063357), submitted by Greiner Bio-One North America, Inc..
- 510(k) Number: K063357
- Device Classification: Tubes, Vials, Systems, Serum Separators, Blood Collection
- Applicant: Greiner Bio-One North America, Inc.
- Date Received: 11/07/2006
- Decision Date: 07/10/2007
- Decision: Substantially Equivalent (SESE)
- Regulation Number: 862.1675
- Product Code: JKA
- Regulation Medical Specialty: Clinical Chemistry
- Review Panel: Hematology
- Total Pages: 229 (60 unredacted, 73% redacted overall)
What's in this document (sections may appear in any order):
- ✗ 510(k) Summary / Statement: 77% redacted
- ~ Indications for Use: 51% redacted
- ✗ Device Description: 71% redacted
- ~ Substantial Equivalence / Predicate: 41% redacted
- ~ Performance / Bench Testing: 23% redacted
- — Biocompatibility: no distinct section found
- — Software / Cybersecurity: no distinct section found
- ✗ Sterilization / Shelf Life: 63% redacted
- ✗ Labeling / IFU: 63% redacted
- ✗ Clinical Data: 80% redacted
- ✗ FDA Correspondence: 90% redacted
- — Risk Analysis / FMEA: no distinct section found
- — Electromagnetic Compatibility (EMC): no distinct section found
Section contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.
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