FDA 510(k) Applications for Medical Device Product Code "JCE"
(Solution, Isotonic)

FDA 510(k) Number Applicant Device Name Decision Date
K761170 BIO/DATA CORP. BARBITAL SALINE BUFFER 01/10/1977
K761174 BIO/DATA CORP. PHYSIOLOGIC SALINE (0.85%) 01/10/1977
K761183 CENTRAL LABS. ASSOC. MD PATHOLOGISTS LYSING AGENT AF 01/17/1977
K792101 COULTER ELECTRONICS, INC. COUITER/CMS ISOTONIC BLOOD BANK SALINE 11/20/1979
K842722 E K IND., INC. BUFFERED SALINE 09/11/1984
K831200 EMD CHEMICALS INC. IMMUNOHEMATOLOGICAL SALINE #97139 05/09/1983
K801506 NOBEL SCIENTIFIC INDUSTRIES, INC. CERTIFIED BLOOD BANK SALINE 07/28/1980


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