QUANTECH TOTAL B-HCG ASSAY
FDA 510(k) clearance K990258 · decided 1999-12-21
Clearance details
- K-number
- K990258
- Device name
- QUANTECH TOTAL B-HCG ASSAY
- Applicant
- Quantech , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1999-01-27
- Decision date
- 1999-12-21
- Days to decision
- 328 days
- Clearance type
- Traditional
- Product code
- NAL
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Northridge, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE (K012943) | Quantech , Ltd. | 2002-01-18 |
Recalls involving this device
No recalls on record reference this clearance.