Solution, Isotonic
Regulation 864.4010
0510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in JCE
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio/Data Corp. | 2 | 0 |
| Central Labs. Assoc. MD Pathologists | 1 | 0 |
| Coulter Electronics, Inc. | 1 | 0 |
| E K Ind., Inc. | 1 | 0 |
| Emd Chemicals, Inc. | 1 | 0 |
| Nobel Scientific Industries, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 1984 | K842722 | BUFFERED SALINE E K Ind., Inc. | JCE |
| May 9, 1983 | K831200 | IMMUNOHEMATOLOGICAL SALINE #97139 Emd Chemicals, Inc. | JCE |
| Jul 28, 1980 | K801506 | CERTIFIED BLOOD BANK SALINE Nobel Scientific Industries, Inc. | JCE |
| Nov 20, 1979 | K792101 | COUITER/CMS ISOTONIC BLOOD BANK SALINE Coulter Electronics, Inc. | JCE |
| Jan 17, 1977 | K761183 | LYSING AGENT AF Central Labs. Assoc. MD Pathologists | JCE |
| Jan 10, 1977 | K761174 | PHYSIOLOGIC SALINE (0.85%) Bio/Data Corp. | JCE |
| Jan 10, 1977 | K761170 | BARBITAL SALINE BUFFER Bio/Data Corp. | JCE |
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