FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
K Number: K983599
·
Decision Dec 11, 1998
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
72
Applicant Total
3
Review Days
58
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Basic Information
- Device Name
- SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
- K Number
- K983599
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Andwin Scientific
- Date Received
- October 14, 1998
- Decision Date
- December 11, 1998
- Product Code
- HHT
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| HHT | Spatula, Cervical, Cytological | FDA class 2 | Obstetrics/Gynecology |
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