Product code NAL— Clinical Chemistry
QUANTECH TOTAL B-HCG ASSAY
- Classification name
- Test, Immunoassay, Biosensor, Hcg
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code NAL
FDA has cleared devices under product code NAL between 1999 and 2002, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2002
- 1999
Top applicants under product code NAL
Recent clearances under product code NAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.