510(k) K133083
- Device
- DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
- Applicant
- DIAZYME LABORATORIES
- 510(k) number
- K133083
- Product code
- DBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-06-24
- Date received
- 2013-09-30
- Regulation
- 866.5340
- Classification name
- Ferritin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Abhijit Datta
- Address
- 12889 Gregg Ct. Poway CA US 92064 92064
FDA Registration Numbers#
- 2084025
- 3015969360
- 3005094123
- 3006198300
- 3006677029
- 3005360469
- 3003795116
- 9610806
- 9680746
- 2050012
- 3005333358
- 2432235
- 9610529
- 3022178699
- 3004434309
- 1832216
- 3002809144
- 9612316
- 3009518015
- 2517506
- 2247288
- 8031673
- 1827821
- 2032682
- 9610746
- 3019906
- 3004493545
- 3005984081
- 2050010
- 8020888
- 3003871639
- 1219913
- 9610240
- 3005529799
- 3007111389
- 9610126
- 2029372
- 1319681
- 3000148879
- 3005655287
- 2032839
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DBF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K193650 | LIAISON Ferritin | DiaSorin, Inc. | 2021-09-14 |
| K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor | HORIBA ABX SAS | 2020-03-06 |
| K171642 | Atellica IM Ferritin Assay | Siemens Healthcare Diagnostics, Inc. | 2017-08-31 |
| K121232 | K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR | Kamiya Biomedical Company | 2012-05-24 |
| K110736 | ADVIA CHEMISTRY FERRITIN (FRT) METHOD | Siemens Healthcare Diagnostics, Inc. | 2011-08-17 |
| K100538 | TINA-QUANT FERRITIN GEN. 4 | Roche Diagnostics | 2010-06-22 |
| K092505 | BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 | Beckman Coulter, Inc. | 2009-12-11 |
| K062746 | FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 | Medicon Hellas S.A | 2006-11-20 |
| K053211 | RDI HSFERRITIN KIT | Reference Diagnostics, Inc. | 2006-03-13 |
| K052617 | FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, | Good Biotech Corp. | 2006-02-23 |
| K050944 | K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET | Kamiya Biomedical Co. | 2005-12-23 |
| K040879 | QUANTEX FERRITIN | Instrumentation Laboratory CO | 2004-05-10 |
| K031650 | FERRITIN GENERATION 2 | Roche Diagnostics Corp. | 2003-07-17 |
| K030124 | OLYMPUS FERRITIN REAGENT | Olympus America, Inc. | 2003-02-06 |
| K014293 | K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET | Kamiya Biomedical Co. | 2002-02-19 |
Legacy Summary#
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FDA Review#
Decision Summary