FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SASI-DC1TS
K Number: K970580
·
Decision Apr 17, 1997
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
3
Applicant Total
1
Review Days
62
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Basic Information
- Device Name
- SASI-DC1TS
- K Number
- K970580
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Substance Abuse Specialties, Inc.
- Date Received
- February 14, 1997
- Decision Date
- April 17, 1997
- 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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