FERRITIN-LATEX, MODELS 1418-2070, 1418-0279
FDA 510(k) clearance K062746 · decided 2006-11-20
Clearance details
- K-number
- K062746
- Device name
- FERRITIN-LATEX, MODELS 1418-2070, 1418-0279
- Applicant
- Medicon Hellas S.A
- Decision
- Substantially Equivalent
- Date received
- 2006-09-14
- Decision date
- 2006-11-20
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- DBF
- Device class
- 2
- Regulation number
- 866.5340
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Gerakas, Attiki, GR
- Third-party review
- Yes
- 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 |
|---|
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| Atellica IM Ferritin Assay (K171642) | Siemens Healthcare Diagnostics, Inc. | 2017-08-31 |
| DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET (K133083) | Diazyme Laboratories | 2014-06-24 |
| K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR (K121232) | Kamiya Biomedical Company | 2012-05-24 |
| ADVIA CHEMISTRY FERRITIN (FRT) METHOD (K110736) | Siemens Healthcare Diagnostics, Inc. | 2011-08-17 |
| TINA-QUANT FERRITIN GEN. 4 (K100538) | Roche Diagnostics | 2010-06-22 |
| BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 (K092505) | Beckman Coulter, Inc. | 2009-12-11 |
| RDI HSFERRITIN KIT (K053211) | Reference Diagnostics, Inc. | 2006-03-13 |
| FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, (K052617) | Good Biotech Corp. | 2006-02-23 |
| K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET (K050944) | Kamiya Biomedical Co. | 2005-12-23 |
| QUANTEX FERRITIN (K040879) | Instrumentation Laboratory CO | 2004-05-10 |
Recalls involving this device
No recalls on record reference this clearance.