ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
FDA 510(k) clearance K161899 · decided 2016-07-28
Clearance details
- K-number
- K161899
- Device name
- ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
- Applicant
- Phadia AB
- Decision
- Substantially Equivalent
- Date received
- 2016-07-11
- Decision date
- 2016-07-28
- Days to decision
- 17 days
- Clearance type
- Special
- Product code
- DGC
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Uppsala, SE
- 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 |
|---|---|---|
| Kenota 1 Total IgE; Kenota 1 (instrument) (K231151) | Kenota, Inc. | 2024-05-31 |
| Quantia IgE (K214068) | Biokit, S.A. | 2023-02-21 |
| Total Immunoglobulin E (IgE) (K220178) | Beckman Coulter, Inc. | 2022-03-23 |
| ADVIA Centaur Total IgE (tIgE) (K193493) | Siemens Healthcare Diagnostics, Inc. | 2020-01-15 |
| IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH (K133404) | Phadia AB | 2014-02-24 |
| DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH (K063425) | Dade Behring, Inc. | 2007-02-15 |
| QUANTIA IGE (K050493) | Biokit, S.A. | 2005-08-16 |
| K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C (K042241) | Kamiya Biomedical Co. | 2004-12-10 |
| LACRYTEST (K034057) | Adiatec SA | 2004-03-09 |
| IMMUNETECH TOTAL IGE SYSTEM (K032251) | Immunetech Corporation | 2003-12-19 |
| IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR (K024210) | Beckman Coulter, Inc. | 2003-02-24 |
| RANDOX IGE (K010855) | Randox Laboratories, Ltd. | 2001-05-15 |
Recalls involving this device
No recalls on record reference this clearance.