FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTECH TOTAL B-HCG ASSAY
K Number: K990258
·
Decision Dec 21, 1999
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
3
Review Days
328
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- QUANTECH TOTAL B-HCG ASSAY
- K Number
- K990258
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quantech , Ltd.
- Date Received
- January 27, 1999
- Decision Date
- December 21, 1999
- Product Code
- NAL
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NAL | Test, Immunoassay, Biosensor, Hcg | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NAL), ordered by most recent decision date.
View all