Scrippsystem Immunoglobin Rid Kit
FDA 510(k) K812453 · Scripps-Miles, Inc.
510(k) numberK812453
Submission
- Device name
- Scrippsystem Immunoglobin Rid Kit
- Applicant
- Scripps-Miles, Inc.
Mchenry, IL, US - Received
- August 28, 1981
- Decision date
- September 23, 1981
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K812328 | Scrippsystem Nephelometric Antisera KitDEW · Traditional | 09/08/1981SE |
| K811714 | HEP-2-CRITHIDIA Luciliae Ana Test KitDHN · Traditional | 07/10/1981SE |
| K811433 | Scrippsera Complement Control SeraDHL · Traditional | 06/16/1981SE |
| K810502 | Scrippsystem C4 Rid KitDBI · Traditional | 04/08/1981SE |
| K810501 | Scrippsystem C3 Rid KitCZW · Traditional | 04/08/1981SE |
| K810221 | Scrippsera Theumatoid Factor Refer. CNTLDHR · Traditional | 02/09/1981SE |
| K810141 | Scrippsystem Rheumatoid Factor Latex KitDHR · Traditional | 02/09/1981SE |
| K810081 | Scrippsera Ana Reference Control SeraDHN · Traditional | 02/09/1981SE |
Questions and answers
When was Scrippsystem Immunoglobin Rid Kit cleared by the FDA?
Scrippsystem Immunoglobin Rid Kit (K812453) received a 510(k) decision of Substantially Equivalent on September 23, 1981, 26 days after the submission was received.
What is the product code of K812453?
The FDA product code is DEW – Igg, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.