FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICRODILUTION STREP ID. PANEL
K Number: K781367
·
Decision Oct 3, 1978
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
48
Applicant Total
4
Review Days
56
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Basic Information
- Device Name
- MICRODILUTION STREP ID. PANEL
- K Number
- K781367
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Cnr Labs
- Date Received
- August 8, 1978
- Decision Date
- October 3, 1978
- Product Code
- JSS
- 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 |
|---|---|---|---|
| JSS | Kit, Identification, Enterobacteriaceae | FDA class 1 | Microbiology |
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