EARLE'S BALANCED SALTS SOULTION
Device Facts
| Record ID | K810779 |
|---|---|
| Device Name | EARLE'S BALANCED SALTS SOULTION |
| Applicant | Dutchland Laboratories, Inc. |
| Product Code | KIP · Hematology |
| Decision Date | May 13, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.2875 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A balanced salt solution or formulation is a defined mixture of salts and glucose in a simple medium. This device is included as a necessary component of most cell culture systems. This media component controls for pH, osmotic pressure, energy source, and inorganic ions.
