Immunoelectrofilm Kih
FDA 510(k) K770719 · Kallestad Laboratories, Inc.
510(k) numberK770719
Submission
- Device name
- Immunoelectrofilm Kih
- Applicant
- Kallestad Laboratories, Inc.
Mchenry, IL, US - Received
- April 18, 1977
- Decision date
- April 26, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JZS – Electrophoresis Instrumentation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.4500
- Specialty
- Immunology
Other 510(k)s with product code JZS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933123 | Synelisa TG Antibodies/Tpo AntibodiesJZS · Traditional | Elias U.S.A., Inc. | 08/23/1993SE |
| K812194 | Immunodiffusion Band Intensifying FluidJZS · Traditional | American Scientific Products | 08/31/1981SE |
| K770566 | Immunoelectrophoresis Profile KitJZS · Traditional | Kallestad Laboratories, Inc. | 04/27/1977SE |
| K770718 | Stain, R-250, Coomassie Brilliant BlueJZS · Traditional | Kallestad Laboratories, Inc. | 04/26/1977SE |
| K770150 | Electro Immuno Assay KitJZS · Traditional | Millipore Corp. | 02/01/1977SE |
More from Millipore Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K863681 | Pathfinder(Tm) Direct Antigen Detection SystemLJP · Traditional | 12/03/1986SE |
| K862917 | Pathfinder Rotavirus ChemiluminescentLIQ · Traditional | 10/22/1986SE |
| K863682 | Pathfinder(Tm) Specimen Collection KitJSM · Traditional | 10/10/1986SE |
| K862743 | Pathfinder(Tm) Respiratory Syncytial VirusGQG · Traditional | 09/29/1986SE |
| K862313 | Kallestad Sm/Rnp Test ReagentLKJ · Traditional | 08/06/1986SE |
| K862710 | Kallestad Ssa/Ssb Ena Test ReagentsLLL · Traditional | 07/29/1986SE |
| K855014 | Quantimetric Plus Calibrator/Control Set aJIX · Traditional | 03/14/1986SE |
| K855010 | Quantimetric Plus Igm Reagent KitDFT · Traditional | 02/28/1986SE |
| K855013 | Quantimetric Plus Support PackDEH · Traditional | 02/26/1986SE |
| K855012 | Quantimetric Plus C4 Reagent KitDBI · Traditional | 02/26/1986SE |
Questions and answers
When was Immunoelectrofilm Kih cleared by the FDA?
Immunoelectrofilm Kih (K770719) received a 510(k) decision of Substantially Equivalent on April 26, 1977, 8 days after the submission was received.
What is the product code of K770719?
The FDA product code is JZS – Electrophoresis Instrumentation, a Class I (low risk) device regulated under 21 CFR 866.4500.