Couiter/Cms Isotonic Blood Bank Saline
FDA 510(k) K792101 · Coulter Electronics, Inc.
510(k) numberK792101
Submission
- Device name
- Couiter/Cms Isotonic Blood Bank Saline
- Applicant
- Coulter Electronics, Inc.
Mchenry, IL, US - Received
- October 19, 1979
- Decision date
- November 20, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code JCE
| 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 |
| 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 |
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| K923530 | Coulter Multi-Q-PrepGKH · Traditional | 10/14/1992SE |
| K922181 | Coulter MH009GKZ · Traditional | 08/17/1992SE |
| K922704 | Coulter Maxm W/ AutoloaderGKZ · Traditional | 07/27/1992SE |
| K921567 | Coulter MH017GKZ · Traditional | 07/06/1992SE |
| K912133 | PX Coulter(R) Cell ControlJPK · Traditional | 07/17/1991SE |
| K911385 | Coulter(R) MH010GKZ · Traditional | 06/17/1991SE |
| K905771 | Coulter Dart Ast (Got) ReagentCIT · Traditional | 02/26/1991SE |
Questions and answers
When was Couiter/Cms Isotonic Blood Bank Saline cleared by the FDA?
Couiter/Cms Isotonic Blood Bank Saline (K792101) received a 510(k) decision of Substantially Equivalent on November 20, 1979, 32 days after the submission was received.
What is the product code of K792101?
The FDA product code is JCE – Solution, Isotonic, a Class I (low risk) device regulated under 21 CFR 864.4010.