ARCHITECT SIROLIMUS ASSAY
FDA 510(k) clearance K070822 · decided 2007-09-28
Clearance details
- K-number
- K070822
- Device name
- ARCHITECT SIROLIMUS ASSAY
- Applicant
- Fujirebio Diagnostics,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-03-26
- Decision date
- 2007-09-28
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- NRP
- Device class
- 2
- Regulation number
- 862.3840
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Fujirebio Diagnostics
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.
| Record | Firm | Date |
|---|---|---|
| EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR (K083487) | Siemens Healthcare Diagnostics | 2009-03-30 |
| DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 (K081857) | Siemens Healthcare Diagnostics, Inc. | 2008-10-30 |
| ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY (K042411) | Axis-Shield , Ltd. | 2005-04-07 |
| CEDIA SIROLIMUS ASSAY (DEN040008) | Microgenics Corp. | 2004-07-28 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL) Anti-Sirolimu recall (Z-2172-2010) | Abbott Laboratories | 2010-08-03 |