FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMMUNOCARD STAT! E. COLI O157 PLUS
K Number: K023599
·
Decision Jan 3, 2003
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
13
Applicant Total
38
Review Days
67
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Basic Information
- Device Name
- IMMUNOCARD STAT! E. COLI O157 PLUS
- K Number
- K023599
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3255
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Meridian Bioscience, Inc.
- Date Received
- October 28, 2002
- Decision Date
- January 3, 2003
- Product Code
- GMZ
- 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 |
|---|---|---|---|
| GMZ | Antigens, All Types, Escherichia Coli | FDA class 1 | Microbiology |
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