FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHIGA TOXIN QUIK CHEK
K Number: K121364
·
Decision Oct 2, 2012
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
13
Applicant Total
5
Review Days
148
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SHIGA TOXIN QUIK CHEK
- K Number
- K121364
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3255
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Techlab Inc., Corporate Research Center
- Date Received
- May 7, 2012
- Decision Date
- October 2, 2012
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GMZ), ordered by most recent decision date.
Curian® Shiga Toxin
FDA 510(k)
FDA Class 1
·Microbiology
SHIGA TOXIN CHEK
FDA 510(k)
FDA Class 1
·Microbiology
IMMUNOCARD STAT! EHEC, MODEL 751630
FDA 510(k)
FDA Class 1
·Microbiology
BIOSTAR OIA SHIGATOX
FDA 510(k)
FDA Class 1
·Microbiology
IMMUNOCARD STAT! E. COLI O157 PLUS
FDA 510(k)
FDA Class 1
·Microbiology
IMMUNOCARD STAT! E. COLI O157:H7
FDA 510(k)
FDA Class 1
·Microbiology