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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 K914818
Device Name DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY
Applicant
Baxter Diagnostics, Inc.
P.O.Box 520672
Miami,  FL  33152
Applicant Contact NANCY A HORNBAKER
Correspondent
Baxter Diagnostics, Inc.
P.O.Box 520672
Miami,  FL  33152
Correspondent Contact NANCY A HORNBAKER
Regulation Number864.7290
Classification Product Code
GGP  
Date Received10/25/1991
Decision Date 01/15/1992
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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