Liss Reagent
FDA 510(k) K790498 · Fisher Scientific Co., LLC
510(k) numberK790498
Submission
- Device name
- Liss Reagent
- Applicant
- Fisher Scientific Co., LLC
Mchenry, IL, US - Received
- March 13, 1979
- Decision date
- April 3, 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 |
| K791113 | Low Ionic Strength Solution (Liss)KSG · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 06/28/1979SE |
| 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 |
| 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 |
|---|---|---|
| K930415 | Microhematocrit RotorGKG · Traditional | 03/23/1993SE |
| K915825 | Marathon 6K General-Purpose CentrifugeGKF · Traditional | 03/11/1992SE |
| K915441 | Marathon 13K/H Microhematocrit CentrifugeGKF · Traditional | 01/08/1992SE |
| K890534 | Modified Uriqual(Tm) Urinalysis Control Level 1JJW · Traditional | 03/08/1989SE |
| K881275 | Uriqual(Tm) Urinalysis Controls (Human) I & IIJJY · Traditional | 05/16/1988SE |
| K874054 | Fisher Diagnostics Hematall III Las ReagentGGK · Traditional | 10/20/1987SE |
| K872916 | Histomatic Slide Stainer, Code-On VersionKPA · Traditional | 09/14/1987SE |
| K871058 | Serachem Liquid Spinal Fluid Control (Human)JJY · Traditional | 04/06/1987SE |
| K863224 | Hematall-C Plus Hematology ControlsJPK · Traditional | 10/29/1986SE |
| K862318 | Fisher Diagnostics Hematall-C CalibratorJPK · Traditional | 07/10/1986SE |
Questions and answers
When was Liss Reagent cleared by the FDA?
Liss Reagent (K790498) received a 510(k) decision of Substantially Equivalent on April 3, 1979, 21 days after the submission was received.
What is the product code of K790498?
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.