Immunology Control Serum
FDA 510(k) K810056 · Icl Scientific
510(k) numberK810056
Submission
- Device name
- Immunology Control Serum
- Applicant
- Icl Scientific
Mchenry, IL, US - Received
- January 13, 1981
- Decision date
- February 9, 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
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|---|---|---|
| K883942 | Hycor Sentry Drugs of Abuse Urine ControlJJY · Traditional | 11/10/1988SE |
| K843565 | Kova Trol I,Ii, III Human Urine-DriedJJW · Traditional | 10/05/1984SE |
| K833761 | Therapeutic Drug ControlDKB · Traditional | 01/13/1984SE |
| K832823 | Enzymune-Test TSHJLW · Traditional | 10/14/1983SE |
| K831383 | Event-Test SlideJHJ · Traditional | 06/22/1983SE |
| K823199 | Enzyme-Test DigoxinKXT · Traditional | 11/29/1982SE |
| K822777 | Therapeutic Drug ControlDIF · Traditional | 10/08/1982SE |
| K822346 | Histimune Enzyme-Ana TestLJM · Traditional | 10/08/1982SE |
| K822465 | Enzymune System IJJE · Traditional | 09/14/1982SE |
| K821374 | Enzymune-Test InsulinCFP · Traditional | 05/28/1982SE |
Questions and answers
When was Immunology Control Serum cleared by the FDA?
Immunology Control Serum (K810056) received a 510(k) decision of Substantially Equivalent on February 9, 1981, 27 days after the submission was received.
What is the product code of K810056?
The FDA product code is DEW – Igg, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.