FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SEPTI-CHECK BLOOD CULTURE SLIDE
K Number: K812731
·
Decision Oct 19, 1981
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
49
Review Days
21
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Basic Information
- Device Name
- SEPTI-CHECK BLOOD CULTURE SLIDE
- K Number
- K812731
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Hoffmann-La Roche, Inc.
- Date Received
- September 28, 1981
- Decision Date
- October 19, 1981
- Product Code
- JSI
- 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | FDA class 1 | Microbiology |
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