FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GONOSTAT
K Number: K883486
·
Decision Aug 15, 1989
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
44
Applicant Total
3
Review Days
364
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Basic Information
- Device Name
- GONOSTAT
- K Number
- K883486
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Technology Management & Marketing, Inc.
- Date Received
- August 16, 1988
- Decision Date
- August 15, 1989
- Product Code
- LSL
- Advisory Committee
- Microbiology
- 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 |
|---|---|---|---|
| LSL | Dna-Reagents, Neisseria | FDA class 2 | Microbiology |
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