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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K881037
Device Name SPECTROLYSE/FIBRIN
Applicant
Cytrx Biopool, Ltd.
150 Technology Pkwy.
Technology Park/Atlanta
Norcross,  GA  30092
Applicant Contact HERRON, DVM
Correspondent
Cytrx Biopool, Ltd.
150 Technology Pkwy.
Technology Park/Atlanta
Norcross,  GA  30092
Correspondent Contact HERRON, DVM
Regulation Number864.7290
Classification Product Code
GGP  
Date Received03/11/1988
Decision Date 07/01/1988
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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