Certified Blood Bank Saline
FDA 510(k) K801506 · Nobel Scientific Industries, Inc.
510(k) numberK801506
Submission
- Device name
- Certified Blood Bank Saline
- Applicant
- Nobel Scientific Industries, Inc.
Mchenry, IL, US - Received
- June 30, 1980
- Decision date
- July 28, 1980
- 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 |
| 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 |
More from Bio/Data Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K854717 | Nsi Astra TM Total Protein Reagent Kit, Nsi #7928CEK · Traditional | 01/14/1986SE |
| K854716 | Nsi Astra TM Calcium Reagent Kit Nsi Item # 7909CIC · Traditional | 01/07/1986SE |
| K854718 | Nsi Astra TM Albumin Reagent Kit Nsi Item # 7926CIX · Traditional | 12/19/1985SE |
| K850944 | Nsi Lysing-D Reagent -4000 MLGGK · Traditional | 03/29/1985SE |
| K844782 | Nsi Elt-D Diluting Fluid 4000MLGIF · Traditional | 03/05/1985SE |
| K823283 | Flushing Solution · Traditional | 12/03/1982SE |
| K812866 | Astra Reagent Concentrate SystemCGA · Traditional | 12/17/1981SE |
| K810550 | Silver AnodeJFS · Traditional | 04/08/1981SE |
| K810549 | Thermal Printer PaperJJE · Traditional | 04/08/1981SE |
| K802518 | Bun Reagent Astra 4 & 8 AnalyzersCDN · Traditional | 11/12/1980SE |
Questions and answers
When was Certified Blood Bank Saline cleared by the FDA?
Certified Blood Bank Saline (K801506) received a 510(k) decision of Substantially Equivalent on July 28, 1980, 28 days after the submission was received.
What is the product code of K801506?
The FDA product code is JCE – Solution, Isotonic, a Class I (low risk) device regulated under 21 CFR 864.4010.