Immu-Sal Immunohematological Saline
FDA 510(k) K761303 · Dade, Baxter Travenol Diagnostics, Inc.
510(k) numberK761303
Submission
- Device name
- Immu-Sal Immunohematological Saline
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
Mchenry, IL, US - Received
- December 22, 1976
- Decision date
- December 30, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KSS – Supplies, Blood-Bank
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.9050
- Specialty
- Hematology
Other 510(k)s with product code KSS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K874436 | Fluid Sampling PackKSS · Traditional | U.S. Mfg. & Management, Inc. | 01/05/1988SE |
| K812892 | S/P Serum Dropper PipetsKSS · Traditional | American Dade | 10/27/1981SE |
| K801516 | Pre-Dent System ModifiedKSS · Traditional | Pre-Dent System | 07/14/1980SE |
| K801386 | Pre-Dent System or Pre-Dent IIKSS · Traditional | Pre-Dent System | 07/14/1980SE |
| K800736 | Pre-Dent SystemKSS · Traditional | Pre-Dent System | 04/24/1980SE |
More from Pre-Dent System
| 510(k) | Device | Decision |
|---|---|---|
| K800296 | Whole Blood Gas Control, Levels 1,2,&3GGM · Traditional | 03/05/1980SE |
| K792606 | Whole Blood Platelet Control Normal,JPK · Traditional | 02/13/1980SE |
| K792723 | Blood Fluid FiltersJKA · Traditional | 01/21/1980SE |
| K792607 | T3 Uptake (T3U) ReagentsKHQ · Traditional | 01/16/1980SE |
| K792443 | TSH RadioimmunoassayJLW · Traditional | 12/27/1979SE |
| K792442 | Ferritin RadioimmunoassayDBF · Traditional | 12/18/1979SE |
| K791922 | Harleco Brand Clinicard Lipase Test SetCET · Traditional | 11/27/1979SE |
| K792183 | Dade High Density Lipoprotein CholesteroLBS · Traditional | 11/13/1979SE |
| K790776 | Dade Low Ionic Strength Soluition (Liss)KSG · Traditional | 05/23/1979SE |
| K790767 | Immu-Tek Automatic CentrifugeKSN · Traditional | 05/23/1979SE |
Questions and answers
When was Immu-Sal Immunohematological Saline cleared by the FDA?
Immu-Sal Immunohematological Saline (K761303) received a 510(k) decision of Substantially Equivalent on December 30, 1976, 8 days after the submission was received.
What is the product code of K761303?
The FDA product code is KSS – Supplies, Blood-Bank, a Class I (low risk) device regulated under 21 CFR 864.9050.