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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase
510(k) Number K850680
Device Name ENCORE FERRITIN REAGENT
Applicant
Hybritech, Inc.
11095 Torreyana Rd.
P.O. Box 269006
San Diego,  CA  92126
Applicant Contact JOHN F BRUNI
Correspondent
Hybritech, Inc.
11095 Torreyana Rd.
P.O. Box 269006
San Diego,  CA  92126
Correspondent Contact JOHN F BRUNI
Regulation Number864.7360
Classification Product Code
JMB  
Date Received02/21/1985
Decision Date 03/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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