Physiologic Saline (0.85%)
FDA 510(k) K761174 · Bio/Data Corp.
510(k) numberK761174
Submission
- Device name
- Physiologic Saline (0.85%)
- Applicant
- Bio/Data Corp.
Mchenry, IL, US - Received
- December 1, 1976
- Decision date
- January 10, 1977
- 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 |
| 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 |
| K761170 | Barbital Saline BufferJCE · Traditional | Bio/Data Corp. | 01/10/1977SE |
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| K943153 | Microsample Coagulation AnalyzerGKP · Traditional | 03/24/1995SE |
| K893650 | Platelet Aggregation Profiler Model PAP-4CJPA · Traditional | 06/23/1989SE |
| K881150 | Kinetic Fibrinogen AssayGIS · Traditional | 03/28/1988SE |
| K873382 | Platelet Extract ReagentGGW · Traditional | 11/20/1987SE |
| K860751 | Von Willebrand Fac. Defic. Abnormal Control PlasmaJPK · Traditional | 03/18/1986SE |
| K860342 | Microsample Coagulation Analyser, Model 110WPJPA · Traditional | 03/04/1986SE |
| K854546 | Microsample Coagulation Analyser Model 110PJPA · Traditional | 01/07/1986SE |
| K853897 | Citrex HGGW · Traditional | 10/10/1985SE |
| K853246 | Calcium ChlorideJPA · Traditional | 08/13/1985SE |
Questions and answers
When was Physiologic Saline (0.85%) cleared by the FDA?
Physiologic Saline (0.85%) (K761174) received a 510(k) decision of Substantially Equivalent on January 10, 1977, 40 days after the submission was received.
What is the product code of K761174?
The FDA product code is JCE – Solution, Isotonic, a Class I (low risk) device regulated under 21 CFR 864.4010.