FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM
K Number: K944319
·
Decision Dec 15, 1994
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
4
Review Days
104
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Basic Information
- Device Name
- BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM
- K Number
- K944319
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2850
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Giles Scientific, Inc.
- Date Received
- September 2, 1994
- Decision Date
- December 15, 1994
- Product Code
- KZK
- 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 |
|---|---|---|---|
| KZK | Reader, Zone, Automated | FDA class 1 | Microbiology |
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