510(k) K781874

MYCOPLASMA ARGININI FITC (30-403-41) by Flow Laboratories, Inc. — Product Code KPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1978
Date Received
November 3, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media And Components, Mycoplasma Detection
Device Class
Class I
Regulation Number
864.2360
Review Panel
PA
Submission Type