Low Ionic Strength Solution (Liss)
FDA 510(k) K791113 · Hyland Therapeutic Div., Travenol Laboratories
510(k) numberK791113
Submission
- Device name
- Low Ionic Strength Solution (Liss)
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
Mchenry, IL, US - Received
- June 15, 1979
- Decision date
- June 28, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KSG – Media, Potentiating For In Vitro Diagnostic Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9600
- Specialty
- Hematology
Other 510(k)s with product code KSG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K812565 | Elution SolutionKSG · Traditional | Biological Corp. of America | 10/23/1981SE |
| K812222 | Em-XKSG · Traditional | Biological Corp. of America | 09/23/1981SE |
| K800943 | Pentex Bovine Albumin 30% SolutionKSG · Traditional | Miles Laboratories, Inc. | 05/08/1980SE |
| K800189 | Bovine Albumin 22% & 30% SolutionsKSG · Traditional | Gotham Biologics, Inc. | 02/13/1980SE |
| K791791 | Ortho Antibody Enhancement SolutionKSG · Traditional | Ortho Diagnostics, Inc. | 10/11/1979SE |
| K790973 | Lo-IonKSG · Traditional | Gamma Biologicals, Inc. | 06/15/1979SE |
| K790776 | Dade Low Ionic Strength Soluition (Liss)KSG · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 05/23/1979SE |
| K790498 | Liss ReagentKSG · Traditional | Fisher Scientific Co., LLC | 04/03/1979SE |
| K781435 | Ortho Low Ionic SolutionKSG · Traditional | Ortho Diagnostics, Inc. | 09/14/1978SE |
| K781397 | Em-VKSG · Traditional | Biological Corp. of America | 09/14/1978SE |
More from Biological Corp. of America
| 510(k) | Device | Decision |
|---|---|---|
| K820835 | Alumina Silica-Activated Partial ThromGFO · Traditional | 04/26/1982SE |
| K820192 | Haemophilus Influenzae Type B AntiserumGRP · Traditional | 03/11/1982SE |
| K812220 | Nephelometric Solid Turbidity StandardJIW · Traditional | 08/18/1981SE |
| K810078 | Q-Pak Therapeutic Drug Monit. Control SDIF · Traditional | 02/02/1981SE |
| K810077 | Omega Therapeutic Drug Monit. Control S.DIF · Traditional | 01/28/1981SE |
| K802610 | Alert A,Hdl-Apoliporotein a, Test KitDER · Traditional | 01/05/1981SE |
| K790249 | Test CellsKSF · Traditional | 05/16/1979SE |
| K781225 | Globulin Test, Human Thyroxine BindingCEE · Traditional | 08/31/1978SE |
| K780962 | Automated EnzymeKSK · Traditional | 07/27/1978SE |
| K780785 | Dilutor TransporterJQW · Traditional | 06/14/1978SE |
Questions and answers
When was Low Ionic Strength Solution (Liss) cleared by the FDA?
Low Ionic Strength Solution (Liss) (K791113) received a 510(k) decision of Substantially Equivalent on June 28, 1979, 13 days after the submission was received.
What is the product code of K791113?
The FDA product code is KSG – Media, Potentiating For In Vitro Diagnostic Use, a Class II (moderate risk) device regulated under 21 CFR 864.9600.