FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOGRAM
K Number: K843725
·
Decision May 21, 1985
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
327
Applicant Total
4
Review Days
239
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Basic Information
- Device Name
- BIOGRAM
- K Number
- K843725
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1620
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Giles Scientific, Inc.
- Date Received
- September 24, 1984
- Decision Date
- May 21, 1985
- 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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