510(k) K990258
- Device
- QUANTECH TOTAL B-HCG ASSAY
- Applicant
- QUANTECH LTD.
- 510(k) number
- K990258
- Product code
- NAL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-12-21
- Date received
- 1999-01-27
- 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
- No
Applicant Contact#
- Contact
- ROBIN 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 |
|---|---|---|---|
| K012943 | THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE | Quantech , Ltd. | 2002-01-18 |
Legacy Summary#
summary
FDA Review#
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