JCE · Class I · 21 CFR 864.4010

FDA Product Code JCE: Solution, Isotonic

Leading manufacturers include Bio/Data Corp., Coulter Electronics, Inc. and Nobel Scientific Industries, Inc..

7
Total
7
Cleared
39d
Avg days
1977
Since

FDA 510(k) Cleared Solution, Isotonic Devices (Product Code JCE)

7 devices
1–7 of 7
Cleared Sep 11, 1984
BUFFERED SALINE
K842722
E K Ind., Inc.
Pathology · 60d
Cleared May 09, 1983
IMMUNOHEMATOLOGICAL SALINE #97139
K831200
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Jul 28, 1980
CERTIFIED BLOOD BANK SALINE
K801506
Nobel Scientific Industries, Inc.
Hematology · 28d
Cleared Nov 20, 1979
COUITER/CMS ISOTONIC BLOOD BANK SALINE
K792101
Coulter Electronics, Inc.
Hematology · 32d
Cleared Jan 17, 1977
LYSING AGENT AF
K761183
Central Labs. Assoc. MD Pathologists
Pathology · 46d
Cleared Jan 10, 1977
BARBITAL SALINE BUFFER
K761170
Bio/Data Corp.
Hematology · 40d
Cleared Jan 10, 1977
PHYSIOLOGIC SALINE (0.85%)
K761174
Bio/Data Corp.
Hematology · 40d

About Product Code JCE - Regulatory Context