AIA-PACK FOLATE ASSAY
FDA 510(k) clearance K992365 · decided 1999-08-10
Clearance details
- K-number
- K992365
- Device name
- AIA-PACK FOLATE ASSAY
- Applicant
- Tosoh Medics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-07-15
- Decision date
- 1999-08-10
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- CGN
- Device class
- 2
- Regulation number
- 862.1295
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- South San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Tosoh Medics
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
| Record | Firm | Date |
|---|---|---|
| TOSOH AIA-PACK FOLATE Calibrator Sets, six levels, Catalog Number-020392. The calibrators recall (Z-0082-2007) | Tosoh Bioscience Inc | 2006-10-28 |