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

Page Type
Cleared 510(K)
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)
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