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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tetrazolium int dye-diaphorase, lactate dehydrogenase
510(k) Number K760009
Device Name COLORIMETRIC DETERMINATION (LDH)
Applicant
THE DOW CHEMICAL CO.
4221 Richmond Rd., N.W.
walker,  MI  49534
Correspondent
THE DOW CHEMICAL CO.
4221 Richmond Rd., N.W.
walker,  MI  49534
Regulation Number862.1440
Classification Product Code
CFH  
Date Received06/10/1976
Decision Date 07/20/1976
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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