FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOSURE SPECIMEN COLLECTION CONTAINER
K Number: K873593
·
Decision Nov 25, 1987
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
11
Applicant Total
1
Review Days
82
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Basic Information
- Device Name
- BIOSURE SPECIMEN COLLECTION CONTAINER
- K Number
- K873593
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Biosure, Inc.
- Date Received
- September 4, 1987
- Decision Date
- November 25, 1987
- Product Code
- KDT
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KDT | Container, Specimen Mailer And Storage, Sterile | FDA class 1 | Pathology |
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