FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM
K Number: K913967
·
Decision Oct 18, 1991
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
3
Applicant Total
1
Review Days
43
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Basic Information
- Device Name
- DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM
- K Number
- K913967
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Doxtech, Inc.
- Date Received
- September 5, 1991
- Decision Date
- October 18, 1991
- Product Code
- KDW
- Advisory Committee
- Pathology
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KDW | Container, Specimen Mailer And Storage, Temperature Controlled, Sterile | FDA class 1 | Pathology |
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