Goat Lambda-Light Chain Anti-Human Serum
FDA 510(k) K771768 · G.D. Searle and Co.
510(k) numberK771768
Submission
- Device name
- Goat Lambda-Light Chain Anti-Human Serum
- Applicant
- G.D. Searle and Co.
Mchenry, IL, US - Received
- September 19, 1977
- Decision date
- October 7, 1977
- 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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|---|---|---|---|
| K172471 | VENTANA CD30 (Ber-H2) RxDx AssayDEH · Traditional | Ventana Medical Systems, Inc. | 05/08/2018SE |
| K140396 | Freelite Human Lambda Free KitDEH · Traditional | The Binding Site Group , Ltd. | 04/16/2014SE |
| K083601 | Lambda Light ChainsDEH · Traditional | SENTINEL CH. SpA | 06/22/2009SE |
| K033811 | Freelite Human Kappa and Lambda Free Kits for Use on the Olympus Au AnalyzerDEH · Traditional | The Binding Site, Ltd. | 01/30/2004SE |
| 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 |
|---|---|---|
| K821159 | In-Line Oxygen Monitoring SystemDRY · Traditional | 05/25/1982SE |
| K811068 | Bypass CoilKPY · Traditional | 05/27/1981SE |
| K811071 | Venous Oxygen ProbeCCE · Traditional | 05/05/1981SE |
| K803238 | Intravascular CatheterFOZ · Traditional | 04/23/1981SE |
| K810630 | Silicone Elastomer Coated Latex FoleyKOD · Traditional | 03/31/1981SE |
| K810131 | Administration SetFPD · Traditional | 02/26/1981SE |
| K802485 | Searle Vascular LoopsKDC · Traditional | 02/12/1981SE |
| K801805 | Metronidazole DiscsJWY · Traditional | 02/10/1981SE |
| K810112 | SWR Disposable Prep RazorKDC · Traditional | 02/04/1981SE |
| K802280 | White Knight Drape SealKKX · Traditional | 10/10/1980SE |
Questions and answers
When was Goat Lambda-Light Chain Anti-Human Serum cleared by the FDA?
Goat Lambda-Light Chain Anti-Human Serum (K771768) received a 510(k) decision of Substantially Equivalent on October 7, 1977, 18 days after the submission was received.
What is the product code of K771768?
The FDA product code is DEH – Lambda, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.