FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADAMS SCIENTIFIC SENSITIVITY DISCS
K Number: K925969
·
Decision Feb 12, 1993
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
327
Applicant Total
2
Review Days
79
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Basic Information
- Device Name
- ADAMS SCIENTIFIC SENSITIVITY DISCS
- K Number
- K925969
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1620
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Adams Scientific, Inc.
- Date Received
- November 25, 1992
- Decision Date
- February 12, 1993
- Product Code
- JTN
- 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 |
|---|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | FDA class 2 | Microbiology |
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Other Clearances by Adams Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K932052 | ADAMS SCIENTIFIC SENSITIVITY DISCS | Jul 19, 1993 | Substantially Equivalent |