Atlas FDA

TINA-QUANT FERRITIN GEN. 4

FDA 510(k) clearance K100538 · decided 2010-06-22

Clearance details

K-number
K100538
Device name
TINA-QUANT FERRITIN GEN. 4
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2010-02-25
Decision date
2010-06-22
Days to decision
117 days
Clearance type
Traditional
Product code
DBF
Device class
2
Regulation number
866.5340
Medical specialty
Immunology
Advisory committee
Immunology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR (K121232)Kamiya Biomedical Company2012-05-24
ADVIA CHEMISTRY FERRITIN (FRT) METHOD (K110736)Siemens Healthcare Diagnostics, Inc.2011-08-17
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 (K092505)Beckman Coulter, Inc.2009-12-11
FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 (K062746)Medicon Hellas S.A2006-11-20
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
QUANTEX FERRITIN (K040879)Instrumentation Laboratory CO2004-05-10

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S007)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S006)Roche Diagnostics2024-10-03
Elecsys Anti-HBs / Elecsys HBs II (P190034/S009)Roche Diagnostics2024-10-03
Elecsys Anti-HBs II (P190034/S008)Roche Diagnostics2024-08-29
Elecsys Anti-HBe (P190005/S005)Roche Diagnostics2024-08-29
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007)Roche Diagnostics2024-07-23
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005)Roche Diagnostics2024-05-01