510(k) K012943
K012943 is an FDA 510(k) premarket notification submitted by Quantech , Ltd. for the device "THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE". The FDA issued a decision of Substantially Equivalent on January 18, 2002. The device falls under product code NAL (Test, Immunoassay, Biosensor, Hcg), a Class II device regulated under 21 CFR 862.1155. Quantech , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2002
- Date Received
- August 31, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Immunoassay, Biosensor, Hcg
- Device Class
- Class II
- Regulation Number
- 862.1155
- Review Panel
- CH
- Submission Type