AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501
FDA 510(k) clearance K974505 · decided 1998-02-17
Clearance details
- K-number
- K974505
- Device name
- AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501
- Applicant
- Alfa Biotech (Uk) , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-01
- Decision date
- 1998-02-17
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- DBF
- Device class
- 2
- Regulation number
- 866.5340
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Aldershot Hants, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Alfa Biotech (Uk)
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.