THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE
FDA 510(k) clearance K012943 · decided 2002-01-18
Clearance details
- K-number
- K012943
- Device name
- THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE
- Applicant
- Quantech , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-31
- Decision date
- 2002-01-18
- Days to decision
- 140 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 |
|---|---|---|
| QUANTECH TOTAL B-HCG ASSAY (K990258) | Quantech , Ltd. | 1999-12-21 |
Recalls involving this device
No recalls on record reference this clearance.