LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET.
FDA 510(k) clearance K901075 · decided 1990-04-02
Clearance details
- K-number
- K901075
- Device name
- LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET.
- Applicant
- London Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-03-08
- Decision date
- 1990-04-02
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- DBF
- Device class
- 2
- Regulation number
- 866.5340
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Eden Prairie, MN, US
- 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 |
|---|
| LIAISON Ferritin (K193650) | DiaSorin, Inc. | 2021-09-14 |
| Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor (K191562) | HORIBA ABX SAS | 2020-03-06 |
| 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 |
| FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 (K062746) | Medicon Hellas S.A | 2006-11-20 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.