NAL — Test, Immunoassay, Biosensor, Hcg Class II
FDA Device Classification
Classification Details
- Product Code
- NAL
- Device Class
- Class II
- Regulation Number
- 862.1155
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K012943 | quantech | THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST | January 18, 2002 |
| K990258 | quantech | QUANTECH TOTAL B-HCG ASSAY | December 21, 1999 |