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510(k) K923951

CD8 CYTOSPHERES KIT by Coulter Electronics, Inc. — Product Code MAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1994
Date Received
August 6, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna-Probe, B And T Lymphocyte
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

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