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FDA Product Code

FDA Product Code JCE — Clearance Directory

Device Class
Class I
Assigned Panel
Pathology
21 CFR Citation
864.4010

510(k) Clearances — 7 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K842722 BUFFERED SALINE E K Ind., Inc. 1984-09-11 Traditional PDF ↗
K831200 IMMUNOHEMATOLOGICAL SALINE #97139 Emd Chemicals, Inc. 1983-05-09 Traditional PDF ↗
K801506 CERTIFIED BLOOD BANK SALINE Nobel Scientific Industries, Inc. 1980-07-28 Traditional PDF ↗
K792101 COUITER/CMS ISOTONIC BLOOD BANK SALINE Coulter Electronics, Inc. 1979-11-20 Traditional PDF ↗
K761183 LYSING AGENT AF Central Labs. Assoc. MD Pathologists 1977-01-17 Traditional PDF ↗
K761174 PHYSIOLOGIC SALINE (0.85%) Bio/Data Corp. 1977-01-10 Traditional PDF ↗
K761170 BARBITAL SALINE BUFFER Bio/Data Corp. 1977-01-10 Traditional PDF ↗

Product code JCE · Class I · Pathology. Data: openFDA.