Lancer L-Ina Anti-Igg
FDA 510(k) K791403 · Sherwood Medical Co.
510(k) numberK791403
Submission
- Device name
- Lancer L-Ina Anti-Igg
- Applicant
- Sherwood Medical Co.
Mchenry, IL, US - Received
- July 30, 1979
- Decision date
- October 17, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DEW – Igg, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code DEW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050113 | Tina-Quant Igg GEN.2DEW · Traditional | Roche Diagnostics Corp. | 02/08/2005SE |
| K040434 | Roche Diagnostics Tina-Quant Igg GEN.2DEW · Special | Roche Diagnostics Corp. | 03/10/2004SE |
| K010617 | Spife Ife Calibrator and Control KitDEW · Traditional | Helena Laboratories | 03/15/2001SE |
| K993928 | Wako-Igg Ii-Ha, Immunoglobulin Calibrator Set, Immunolobulin StandardDEW · Traditional | Wako Chemicals USA, Inc. | 01/18/2000SE |
| K993281 | K-Assay IggDEW · Traditional | Kamiya Biomedical Co. | 11/09/1999SE |
| K983221 | IggDEW · Traditional | Abbott Laboratories | 11/04/1998SE |
| K965108 | Synchron LX Systems Immunoglobulin G/A/M ReagentDEW · Traditional | Beckman Instruments, Inc. | 03/06/1997SE |
| K963974 | Image-Immunochemistry System Urine ImmunoglobulinDEW · Traditional | Beckman Instruments, Inc. | 03/06/1997SE |
| K963868 | Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm)DEW · Traditional | Beckman Instruments, Inc. | 02/10/1997SE |
| K962202 | Quantex IggDEW · Traditional | Instrumentation Laboratory CO | 09/26/1996SE |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K981365 | Mahurkar 13.5 FR Cuffed Catheter with Curved ExtensionsMSD · Traditional | 11/25/1998SE |
| K960982 | Monoject Blunt I.V. Access Cannula/Monoject Hypodermic Syringe with Blunt I.V. Access…FMI · Traditional | 12/23/1996SE |
| K962880 | Sensi-Touch Combo Spinal/Epidural Regional Anesthesia Delivery SystemCAZ · Traditional | 12/09/1996SESK |
| K960574 | Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray and Thoracic Catheter…FHO · Traditional | 08/05/1996SE |
| K960677 | Kangaroo Jejunal Feeding SystemKNT · Traditional | 05/13/1996SE |
| K960632 | Kangaroo Feeding Tube Placment StyletKNT · Traditional | 05/09/1996SE |
| K955831 | Argyle Aspr-Care Closed Suction SystemBSY · Traditional | 03/28/1996SE |
| K954429 | Kangaroo Entristar Skin-Level Gastrostomy KitKNT · Traditional | 03/08/1996SESK |
| K954525 | Sensi-Touch Epidural Anesthesia FilterBXN · Traditional | 01/19/1996SE |
| K950201 | Argyle(R) Hydrophilic Coated Thoracic CatheterJOL · Traditional | 12/15/1995SE |
Questions and answers
When was Lancer L-Ina Anti-Igg cleared by the FDA?
Lancer L-Ina Anti-Igg (K791403) received a 510(k) decision of Substantially Equivalent on October 17, 1979, 79 days after the submission was received.
What is the product code of K791403?
The FDA product code is DEW – Igg, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.