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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Screening, For D Positive Fetal Rbc'S
510(k) Number K820647
Device Name GAMMA FETAL BLEED SCREENING TEST
Applicant
Gamma Biologicals, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Gamma Biologicals, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.7455
Classification Product Code
LIM  
Date Received03/09/1982
Decision Date 05/12/1982
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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