FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUIX RAPID E. COLI O157 STRIP TEST
K Number: K972156
·
Decision Oct 16, 1997
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
13
Applicant Total
4
Review Days
129
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Basic Information
- Device Name
- QUIX RAPID E. COLI O157 STRIP TEST
- K Number
- K972156
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3255
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Guardian Scientific, Corp.
- Date Received
- June 9, 1997
- Decision Date
- October 16, 1997
- 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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