Keratin Primary Antibody
FDA 510(k) K940331 · Ventana Medical Systems, Inc.
510(k) numberK940331
Submission
- Device name
- Keratin Primary Antibody
- Applicant
- Ventana Medical Systems, Inc.
Tucson, AZ, US - Received
- January 24, 1994
- Decision date
- February 26, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K242783 | Roche Digital Pathology DxPSY · Special | 12/17/2024SE |
| K232879 | Roche Digital Pathology Dx (VENTANA DP 200)PSY · Traditional | 06/14/2024SE |
| K212176 | CINtec HistologyPRB · Traditional | 12/10/2021SE |
| K172471 | VENTANA CD30 (Ber-H2) RxDx AssayDEH · Traditional | 05/08/2018SE |
| K142965 | Virtuoso System for IHC PR (1E2) using iScan HTOEO · Traditional | 07/16/2015SE |
| K140465 | Virtuoso System for Ihc Er (SP1) with Benchmark Ultra StainerNQN · Traditional | 03/20/2014SE |
| K130515 | Virtuoso System for Ihc Er (Spi)NQN · Traditional | 11/22/2013SE |
| K121516 | Virtuoso System for Ihc HER2 (4B5)NQN · Traditional | 09/26/2013SE |
| K122143 | Virtuoso System for Ihc PR (1E2) Benchmark Ultra StainerNQN · Traditional | 09/19/2013SE |
| K121033 | Virtuoso System for Ihc KI-67 (30-9)NOT · Traditional | 09/06/2013SE |
Questions and answers
When was Keratin Primary Antibody cleared by the FDA?
Keratin Primary Antibody (K940331) received a 510(k) decision of Substantially Equivalent on February 26, 1996, 763 days after the submission was received.
What is the product code of K940331?
The FDA product code is DEH – Lambda, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.