Last synced on 25 January 2026 at 3:41 am

ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K963934
510(k) Type
Traditional
Applicant
Bio-Rad Laboratories, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/16/1996
Days to Decision
76 days
Submission Type
Summary

ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K963934
510(k) Type
Traditional
Applicant
Bio-Rad Laboratories, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/16/1996
Days to Decision
76 days
Submission Type
Summary