Retic-Set
FDA 510(k) K843619 · R&D Systems, Inc.
510(k) numberK843619
Submission
- Device name
- Retic-Set
- Applicant
- R&D Systems, Inc.
Minneapolis, MN, US - Received
- September 14, 1984
- Decision date
- October 30, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQC – Stains, Hematology
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code KQC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882873 | Fieldtex HematoxylinKQC · Traditional | Anatech, Ltd. | 07/28/1988SE |
| K852843 | General Diagnostics Coag-A-Mate XCKQC · Traditional | Warner-Lambert Co. | 08/13/1985SE |
| K841848 | Retic-SetKQC · Traditional | R&D Systems, Inc. | 05/31/1984SE |
| K792550 | Ponceau S Stain SetKQC · Traditional | Electrophoresis Corp. of America | 01/16/1980SE |
| K792496 | Volu-Sol NMB Reticulocyte StainKQC · Traditional | Volu Sol Medical Industries | 12/31/1979SE |
| K791007 | Stat Diff StainKQC · Traditional | Bioscientific | 08/03/1979SE |
| K760487 | Hemastain Phosphate BufferKQC · Traditional | Geometric Data, Div. Smithkline Corp. | 08/30/1976SE |
| K760485 | Hemastain FixativeKQC · Traditional | Geometric Data, Div. Smithkline Corp. | 08/30/1976SE |
More from Geometric Data, Div. Smithkline Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K160606 | BC-5D Hematology ControlJPK · Traditional | 09/01/2016SE |
| K130962 | R&D 5D Retic Hematology ControlJPK · Special | 07/24/2013SE |
| K101578 | R&D Systems Body Fluid-I Hematology ControlJPK · Traditional | 04/28/2011SE |
| K100050 | R & D Systems Xeret Hematology ControlJPK · Special | 01/29/2010SE |
| K091433 | R&D Systems Tetic-I Plus Hemotology ControlJPK · Special | 10/28/2009SE |
| K073178 | HCT Extended Hematology Control, Model HCT004JPK · Traditional | 12/27/2007SE |
| K072846 | CSF Automated Control, Models CSF001, CSF003JPK · Traditional | 11/26/2007SE |
| K072268 | HC WBC Hematology Control, Model: WBC00SJPK · Traditional | 11/20/2007SE |
| K072096 | CBC-5D Plus Retics Hematology Control, Models: 5DR03, 5DR04JPK · Special | 08/20/2007SE |
| K070334 | R&D Sickle QC ControlGGM · Traditional | 03/29/2007SE |
Questions and answers
When was Retic-Set cleared by the FDA?
Retic-Set (K843619) received a 510(k) decision of Substantially Equivalent on October 30, 1984, 46 days after the submission was received.
What is the product code of K843619?
The FDA product code is KQC – Stains, Hematology, a Class I (low risk) device regulated under 21 CFR 864.1850.