Atlas FDA

VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)

FDA 510(k) clearance K973331 · decided 1997-10-22

Clearance details

K-number
K973331
Device name
VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)
Applicant
Ortho-Clinical Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
1997-09-04
Decision date
1997-10-22
Days to decision
48 days
Clearance type
Traditional
Product code
DBF
Device class
2
Regulation number
866.5340
Medical specialty
Immunology
Advisory committee
Immunology
Location
Rochester, NY, 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
TINA-QUANT FERRITIN GEN. 4 (K100538)Roche Diagnostics2010-06-22
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 (K092505)Beckman Coulter, Inc.2009-12-11
FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 (K062746)Medicon Hellas S.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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
VITROS Anti-HBc IgM (P030026/S037)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S018)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S036)Ortho-Clinical Diagnostics, Inc.2020-10-22
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S033)Ortho-Clinical Diagnostics, Inc.2020-08-07
VITROS Anti-HBs (P000014/S035)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S032)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Anti-HBc IgM (P030026/S036)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS HBeAg (P090028/S017)Ortho-Clinical Diagnostics, Inc.2019-06-19