FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPORDEX CULTURE MEDIA
K Number: K850143
·
Decision Mar 5, 1985
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
51
Applicant Total
36
Review Days
50
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Basic Information
- Device Name
- SPORDEX CULTURE MEDIA
- K Number
- K850143
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2350
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- American Sterilizer Co.
- Date Received
- January 14, 1985
- Decision Date
- March 5, 1985
- Product Code
- JSC
- 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 |
|---|---|---|---|
| JSC | Culture Media, General Nutrient Broth | FDA class 1 | Microbiology |
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