FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT
K Number: K802415
·
Decision Oct 31, 1980
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
208
Applicant Total
137
Review Days
25
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Basic Information
- Device Name
- BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT
- K Number
- K802415
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2300
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Remel Co.
- Date Received
- October 6, 1980
- Decision Date
- October 31, 1980
- Product Code
- JSG
- 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 |
|---|---|---|---|
| JSG | Culture Media, Non-Selective And Non-Differential | FDA class 1 | Microbiology |
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