FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECIMEN COLLECTOR
K Number: K770112
·
Decision Mar 14, 1977
Classifications
1
FEI Numbers
294
Registration Numbers
294
Same Product Code
22
Applicant Total
20
Review Days
54
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Basic Information
- Device Name
- SPECIMEN COLLECTOR
- K Number
- K770112
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Portex, Inc.
- Date Received
- January 19, 1977
- Decision Date
- March 14, 1977
- Product Code
- FMH
- Advisory Committee
- Pathology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMH | Container, Specimen, Sterile | FDA class 1 | Pathology |
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