FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GONORRHEA TRANSETTE 1 & 3
K Number: K831579
·
Decision Jun 17, 1983
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
42
Applicant Total
3
Review Days
31
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Basic Information
- Device Name
- GONORRHEA TRANSETTE 1 & 3
- K Number
- K831579
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Spectrum Diagnostic, Inc.
- Date Received
- May 17, 1983
- Decision Date
- June 17, 1983
- Product Code
- JTW
- Advisory Committee
- Microbiology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JTW | System, Transport, Aerobic | FDA class 1 | Microbiology |
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