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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solution, Stabilized Enzyme
510(k) Number K813342
Device Name GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION
Applicant
Gamma Biologicals, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Gamma Biologicals, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.9400
Classification Product Code
KSK  
Date Received11/25/1981
Decision Date 03/04/1982
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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