JCE — Solution, Isotonic Class I
FDA product code JCE covers "Solution, Isotonic", a Class I medical device regulated under 21 CFR 864.4010. Submissions are reviewed by the Pathology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JCE
- Device Class
- Class I
- Regulation Number
- 864.4010
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K842722 | e k ind | BUFFERED SALINE | September 11, 1984 |
| K831200 | emd chemicals | IMMUNOHEMATOLOGICAL SALINE #97139 | May 9, 1983 |
| K801506 | nobel scientific industries | CERTIFIED BLOOD BANK SALINE | July 28, 1980 |
| K792101 | coulter electronics | COUITER/CMS ISOTONIC BLOOD BANK SALINE | November 20, 1979 |
| K761183 | central labs. assoc. md pathologists | LYSING AGENT AF | January 17, 1977 |
| K761170 | bio/data | BARBITAL SALINE BUFFER | January 10, 1977 |
| K761174 | bio/data | PHYSIOLOGIC SALINE (0.85%) | January 10, 1977 |