FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CULTURE MEDIA/ISOLA. PATHO. NEISSERIA
K Number: K780022
·
Decision Jan 20, 1978
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
82
Applicant Total
2
Review Days
16
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Basic Information
- Device Name
- CULTURE MEDIA/ISOLA. PATHO. NEISSERIA
- K Number
- K780022
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.2410
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Culture System
- Date Received
- January 4, 1978
- Decision Date
- January 20, 1978
- Product Code
- JTY
- 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 |
|---|---|---|---|
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | FDA class 2 | Microbiology |
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Other Clearances by Diagnostic Culture System
| K Number | Device Name | ||
|---|---|---|---|
| K780021 | URINE SCREENING KITS | Mar 17, 1978 | Substantially Equivalent |