FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED UNISCEPT KB LABELING AMENDMENT
K Number: K861408
·
Decision May 16, 1986
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
440
Applicant Total
5
Review Days
31
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Basic Information
- Device Name
- MODIFIED UNISCEPT KB LABELING AMENDMENT
- K Number
- K861408
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Analytab Products, Inc.
- Date Received
- April 15, 1986
- Decision Date
- May 16, 1986
- Product Code
- JWY
- 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 |
|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | FDA class 2 | Microbiology |
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