510(k) K012943
- Device
- THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE
- Applicant
- Quantech , Ltd.
- 510(k) number
- K012943
- Product code
- NAL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-01-18
- Date received
- 2001-08-31
- Regulation
- 862.1155
- Classification name
- Test, Immunoassay, Biosensor, Hcg
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- ROBIN J HELLEN
- Address
- 9418 Lasaine Ave. Northridge CA US 91325 91325
Source Documents#
Other 510(k) Records For Product Code NAL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K990258 | QUANTECH TOTAL B-HCG ASSAY | Quantech , Ltd. | 1999-12-21 |