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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name visual, pregnancy hcg, prescription use
510(k) Number K834000
Device Name TANDEM VISUAL HCG IMMUNOENZYMETRIC
Applicant
HYBRITECH, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HYBRITECH, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1155
Classification Product Code
JHI  
Date Received11/21/1983
Decision Date 02/03/1984
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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