FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GULL ELISAWARE
K Number: K912558
·
Decision Sep 16, 1991
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
42
Applicant Total
57
Review Days
97
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Basic Information
- Device Name
- GULL ELISAWARE
- K Number
- K912558
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gull Laboratories, Inc.
- Date Received
- June 11, 1991
- Decision Date
- September 16, 1991
- Product Code
- LIB
- 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 |
|---|---|---|---|
| LIB | Device, General Purpose, Microbiology, Diagnostic | FDA class 1 | Microbiology |
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