Kallestad's Endoplate Factor B Test
FDA 510(k) K811740 · Kallestad Laboratories, Inc.
510(k) numberK811740
Submission
- Device name
- Kallestad's Endoplate Factor B Test
- Applicant
- Kallestad Laboratories, Inc.
Mchenry, IL, US - Received
- June 19, 1981
- Decision date
- July 16, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JZH – Factor B, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5320
- Specialty
- Immunology
Other 510(k)s with product code JZH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964843 | Immage Immunochemistry System Properdin Factor B (PFB) ReagentJZH · Traditional | Beckman Instruments, Inc. | 03/06/1997SE |
| K882623 | Properdin Factor B for Technicon DPA-1(TM) SystemJZH · Traditional | Technicon Instruments Corp. | 07/08/1988SE |
| K831959 | Radial Immuno-Test for Human Factor BJZH · Traditional | Kent Laboratories, Inc. | 07/19/1983SE |
| K781016 | C3PA (GBG) Properdin Factor BJZH · Traditional | Icl Scientific | 08/14/1978SE |
| K772084 | Las-R Human C3 Proactivator TestJZH · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 01/24/1978SE |
More from Hyland Therapeutic Div., Travenol Laboratories
| 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 Kallestad's Endoplate Factor B Test cleared by the FDA?
Kallestad's Endoplate Factor B Test (K811740) received a 510(k) decision of Substantially Equivalent on July 16, 1981, 27 days after the submission was received.
What is the product code of K811740?
The FDA product code is JZH – Factor B, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5320.