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FDA 510(k) Application Details - K971470
Device Classification Name
Device, Automated Cell-Locating
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510(K) Number
K971470
Device Name
Device, Automated Cell-Locating
Applicant
TRIANGLE BIOMEDICAL SCIENCES, INC.
4360 NORTHLAKE BLVD.
SUITE 214
PALM BEACH GARDENS, FL 33410 US
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Contact
RONALD L BARTLEY
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Regulation Number
864.5260
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Classification Product Code
JOY
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More FDA Info for this Product Code
Date Received
04/22/1997
Decision Date
09/16/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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