CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED
FDA 510(k) clearance K060322 · decided 2006-03-21
Clearance details
- K-number
- K060322
- Device name
- CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED
- Applicant
- Cliniqa Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-02-09
- Decision date
- 2006-03-21
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- JIT
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Fallbrook, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cliniqa Corporation
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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 |
|---|---|---|
| VITROS Immunodiagnostic Products Insulin Calibrators (K171168) | Ortho Clinical Diagnostics | 2017-05-16 |
| CalSet IGF-1 (K170938) | Roche Diagnostics | 2017-04-26 |
| Abbott ARCHITECT Free T3 (K170160) | Abbott Laboratories | 2017-02-15 |
| Lumipulse G FSH-N Calibrators (K163534) | Fujirebio Diagnostics,Inc. | 2017-01-13 |
| Lumipulse G Progesterone-N Calibrators (K163546) | Fujirebio Diagnostics,Inc. | 2017-01-13 |
| Lumipulse G Prolactin (K163544) | Fujirebio Diagnostics,Inc. | 2017-01-12 |
| Lumipulse G LH Calibrators (K163521) | Fujirebio Diagnostics,Inc. | 2017-01-12 |
| DC-UIBC-CAL (K163078) | Sekisui Diagnostics P.E.I., Inc. | 2016-12-08 |
| Lumipulse G E2-III Calibrators (K163053) | Fujirebio Diagnostics,Inc. | 2016-12-01 |
| ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator (K162538) | Siemens Healthcare Diagnostics | 2016-11-17 |
| ST AIA-PACK hsE2 Calibrator Set (K160113) | Tosoh Bioscience, Inc. | 2016-02-17 |
| ST AIA-PACK PROG III Calibrator Set (K153417) | Tosoh Bioscience, Inc. | 2015-12-18 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| da Vinci S Surgical System, Model number IS2000 Endoscopic Instrument Control System, manu recall (Z-2204-2008) | Intuitive Surgical, Inc. | 2008-09-16 |
| Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5 s recall (Z-0079-2008) | Intuitive Surgical, Inc. | 2008-02-21 |