Coulter Clone Gam-Fitc Poly Anti (Igg & Igm)
FDA 510(k) K893419 · Coulter Immunology
510(k) numberK893419
Submission
- Device name
- Coulter Clone Gam-Fitc Poly Anti (Igg & Igm)
- Applicant
- Coulter Immunology
Hialeah, FL, US - Received
- May 2, 1989
- Decision date
- August 3, 1989
- 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 |
|---|---|---|
| K922745 | Cyto-Stat/Coulter Clone CD3(IGG1)-FITC/T4-RD1GKZ · Traditional | 02/05/1993SE |
| K922744 | Cyto-Stat/Coulter Clone CD 3(IGG1)-FITC/T8-RD1GKZ · Traditional | 02/05/1993SE |
| K910473 | Cyto-Stat(R)/Coulter Clone(R) T11-RD1/B4-FITCGKZ · Traditional | 10/31/1991SE |
| K911793 | CoultercloneGKZ · Traditional | 07/09/1991SE |
| K893853 | Coulter Clone T8 Monoclonal AntibodyGKZ · Traditional | 03/02/1990SE |
| K893852 | Coulter Clone T4 Monoclonal AntibodyGKZ · Traditional | 03/02/1990SE |
| K894179 | Coulter Clone(R) MY4 Monoclonal AntibodyGKZ · Traditional | 02/12/1990SE |
| K895917 | Cyto-Stat/Coulter Clone T4-RD1/T8-FITC Mono AntiGKZ · Traditional | 12/29/1989SE |
| K884605 | Coulter Clone MO2GKZ · Traditional | 08/15/1989SE |
| K884020 | Coulter Clone B4 Monoclonal AntibodyGKZ · Traditional | 02/03/1989SE |
Questions and answers
When was Coulter Clone Gam-Fitc Poly Anti (Igg & Igm) cleared by the FDA?
Coulter Clone Gam-Fitc Poly Anti (Igg & Igm) (K893419) received a 510(k) decision of Substantially Equivalent on August 3, 1989, 93 days after the submission was received.
What is the product code of K893419?
The FDA product code is DEW – Igg, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.