Amer. Histo-Id Sys Primary Lambda Chain
FDA 510(k) K842328 · Bartels Immunodiagnostic Supplies, Inc.
510(k) numberK842328
Submission
- Device name
- Amer. Histo-Id Sys Primary Lambda Chain
- Applicant
- Bartels Immunodiagnostic Supplies, Inc.
Walker, MI, US - Received
- June 13, 1984
- Decision date
- August 3, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DEH – Lambda, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
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| K140396 | Freelite Human Lambda Free KitDEH · Traditional | The Binding Site Group , Ltd. | 04/16/2014SE |
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| K031016 | Freelite Human Kappa and Lambda Free Kits for Use on the Dad Behring Nephelometer IIDEH · Traditional | The Binding Site, Ltd. | 07/15/2003SE |
| K023131 | Freelite Human Lambda Free KitDEH · Traditional | The Binding Site, Ltd. | 01/21/2003SE |
| K010441 | Freelite Kappa Free KitDEH · Traditional | The Binding Site, Ltd. | 04/26/2001SE |
| K010440 | Freelite Lambda Free KitDEH · Traditional | The Binding Site, Ltd. | 04/26/2001SE |
| K003671 | Lambda Immage Freelite KitDEH · Traditional | The Binding Site, Ltd. | 02/01/2001SE |
| K002563 | Sheep Anti-Human Lambda Free Light Chain Immunofixation Grade KitDEH · Traditional | The Binding Site, Ltd. | 10/26/2000SE |
More from The Binding Site, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K864776 | A549 (Human Lung Carcinoma) Culture CellsKIR · Traditional | 12/31/1986SE |
| K861172 | Rotavirus Latex Agglutination AssayLIQ · Traditional | 07/01/1986SE |
| K860279 | Cytomegalovirus Direct Fluorescent Antibody KitLIN · Traditional | 05/13/1986SE |
| K855034 | American Histo-Id Sys Primary Kit Psa Prostate AntLIJ · Traditional | 03/11/1986SE |
| K842830 | Immunoper-Oxidase Test Kit for Detect ofGQN · Traditional | 11/26/1985SE |
| K852185 | Respiratory Syncytial Virus Direct Fluorescent AntLKT · Traditional | 08/19/1985SE |
| K844105 | Fitc Labeled Chlamydiae Monoclonal Antibody · Traditional | 12/06/1984SE |
| K842834 | HEP-2 CellsKJR · Traditional | 08/28/1984SE |
| K842833 | PMK Primary Monkey Kidney-CellsKJR · Traditional | 08/28/1984SE |
| K842330 | Amer. Histo-Id Sys Primary Iga 2720-21CZP · Traditional | 08/02/1984SE |
Questions and answers
When was Amer. Histo-Id Sys Primary Lambda Chain cleared by the FDA?
Amer. Histo-Id Sys Primary Lambda Chain (K842328) received a 510(k) decision of Substantially Equivalent on August 3, 1984, 51 days after the submission was received.
What is the product code of K842328?
The FDA product code is DEH – Lambda, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.