FDA 510(k) Application Details - K001420

Device Classification Name Device, Automated Cell-Locating

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510(K) Number K001420
Device Name Device, Automated Cell-Locating
Applicant APPLIED IMAGING CORP.
2380 WALSH AVE., BLDG.B
SANTA CLARA, CA 95051 US
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Contact DIANE OATES
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Regulation Number 864.5260

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Classification Product Code JOY
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Date Received 05/05/2000
Decision Date 08/30/2000
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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