FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PREGNOPOST
K Number: K821621
·
Decision Jul 21, 1982
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
11
Applicant Total
1
Review Days
49
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Basic Information
- Device Name
- PREGNOPOST
- K Number
- K821621
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- M.M. Wolfred, Ph.D.
- Date Received
- June 2, 1982
- Decision Date
- July 21, 1982
- Product Code
- KDT
- 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 |
|---|---|---|---|
| KDT | Container, Specimen Mailer And Storage, Sterile | FDA class 1 | Pathology |
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