FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GELRITE
K Number: K820610
·
Decision Oct 27, 1982
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
69
Applicant Total
1
Review Days
233
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Basic Information
- Device Name
- GELRITE
- K Number
- K820610
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2450
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Kelco
- Date Received
- March 8, 1982
- Decision Date
- October 27, 1982
- Product Code
- JSK
- 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 |
|---|---|---|---|
| JSK | Supplement, Culture Media | FDA class 1 | Microbiology |
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