FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE
K Number: K012943
·
Decision Jan 18, 2002
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
3
Review Days
140
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
- THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE
- K Number
- K012943
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quantech , Ltd.
- Date Received
- August 31, 2001
- Decision Date
- January 18, 2002
- Product Code
- NAL
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| NAL | Test, Immunoassay, Biosensor, Hcg | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NAL), ordered by most recent decision date.
View all