Solution, Isotonic
FDA product code JCE · Class I (low risk) · 21 CFR 864.4010 · Pathology
7510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K842722 | Buffered SalineJCE · Traditional | E K Ind., Inc. | 09/11/1984SE |
| K831200 | Immunohematological Saline #97139JCE · Traditional | Emd Chemicals, Inc. | 05/09/1983SE |
| K801506 | Certified Blood Bank SalineJCE · Traditional | Nobel Scientific Industries, Inc. | 07/28/1980SE |
| K792101 | Couiter/Cms Isotonic Blood Bank SalineJCE · Traditional | Coulter Electronics, Inc. | 11/20/1979SE |
| K761183 | Lysing Agent AfJCE · Traditional | Central Labs. Assoc. MD Pathologists | 01/17/1977SE |
| K761174 | Physiologic Saline (0.85%)JCE · Traditional | Bio/Data Corp. | 01/10/1977SE |
| K761170 | Barbital Saline BufferJCE · Traditional | Bio/Data Corp. | 01/10/1977SE |