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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chromatographic Separation, Lecithin/Sphingomyelin Ratio
510(k) Number K834616
Device Name AMNIO STAT-FLM AGGLUTINATION TEST
Applicant
Hana Biologics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hana Biologics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1455
Classification Product Code
JHG  
Date Received12/14/1983
Decision Date 05/25/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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