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FDA 510(k) Application Details - K042424
Device Classification Name
Radioimmunoassay, 17-Hydroxyprogesterone
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510(K) Number
K042424
Device Name
Radioimmunoassay, 17-Hydroxyprogesterone
Applicant
WALLAC OY
MUSTIONKATU 6
TURKU 20750 FI
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Contact
GUNNEL LAAKSONEN
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Regulation Number
862.1395
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Classification Product Code
JLX
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Date Received
09/08/2004
Decision Date
09/30/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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