FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
#4001 TUBED MEDIA - FLUID THIOGLYCOLLATE
K Number: K820796
·
Decision Apr 8, 1982
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
51
Applicant Total
19
Review Days
16
Basic Information
- Device Name
- #4001 TUBED MEDIA - FLUID THIOGLYCOLLATE
- K Number
- K820796
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2350
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- BIOMEDICA, INC.
- Date Received
- March 23, 1982
- Decision Date
- April 8, 1982
- 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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