FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BLOOD CULTURE MEDIA
K Number: K780615
·
Decision May 4, 1978
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
145
Applicant Total
3
Review Days
21
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Basic Information
- Device Name
- BLOOD CULTURE MEDIA
- K Number
- K780615
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Meda Stat Diagnostics, Inc.
- Date Received
- April 13, 1978
- Decision Date
- May 4, 1978
- Product Code
- JSH
- 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 |
|---|---|---|---|
| JSH | Culture Media, Non-Selective And Differential | FDA class 1 | Microbiology |
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