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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Occult Blood
510(k) Number K921798
Device Name PROPPER SUPER SERACULT(R)
Applicant
Propper Mfg. Co., Inc.
3604 Skillman Ave.
Long Island City,  NY  11101
Correspondent
Propper Mfg. Co., Inc.
3604 Skillman Ave.
Long Island City,  NY  11101
Regulation Number864.6550
Classification Product Code
KHE  
Date Received04/14/1992
Decision Date 10/05/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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