Kappa & Lambda Bence Jones Controls
FDA 510(k) K812327 · Kallestad Laboratories, Inc.
510(k) numberK812327
Submission
- Device name
- Kappa & Lambda Bence Jones Controls
- Applicant
- Kallestad Laboratories, Inc.
Mchenry, IL, US - Received
- August 18, 1981
- Decision date
- September 1, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CZQ – Bence-Jones Protein, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5150
- Specialty
- Immunology
Other 510(k)s with product code CZQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K802284 | Antisera to Human Free Lambda Light Ch.CZQ · Traditional | Kallestad Laboratories, Inc. | 10/23/1980SE |
More from Kallestad Laboratories, Inc.
| 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 Kappa & Lambda Bence Jones Controls cleared by the FDA?
Kappa & Lambda Bence Jones Controls (K812327) received a 510(k) decision of Substantially Equivalent on September 1, 1981, 14 days after the submission was received.
What is the product code of K812327?
The FDA product code is CZQ – Bence-Jones Protein, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5150.