FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GRAM SWAB
K Number: K970834
·
Decision Apr 17, 1997
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
243
Applicant Total
17
Review Days
41
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Basic Information
- Device Name
- GRAM SWAB
- K Number
- K970834
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Remel, Inc.
- Date Received
- March 7, 1997
- Decision Date
- April 17, 1997
- Product Code
- JTO
- 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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | FDA class 1 | Microbiology |
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