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510(k) K924289

KALLESTAD RSV MICROPLATE EIA by Bio-Rad Laboratories, Inc. — Product Code MCE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1993
Date Received
August 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Respiratory Syncytial Virus - Elisa
Device Class
Class I
Regulation Number
866.3480
Review Panel
MI
Submission Type

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Other clearances for product code MCE

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