Last synced on 27 June 2025 at 11:06 pm

TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K003064
510(k) Type
Traditional
Applicant
ROCHE DIAGNOSTICS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/1/2001
Days to Decision
211 days
Submission Type
Statement

TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K003064
510(k) Type
Traditional
Applicant
ROCHE DIAGNOSTICS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/1/2001
Days to Decision
211 days
Submission Type
Statement