Anti-Human Globulins
FDA 510(k) K791285 · Diagnostica, Inc.
510(k) numberK791285
Submission
- Device name
- Anti-Human Globulins
- Applicant
- Diagnostica, Inc.
Mchenry, IL, US - Received
- July 10, 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 |
|---|---|---|
| K002756 | Ease-A-CultKHE · Traditional | 02/23/2001SE |
| K823348 | H. Influenza B Antisera for CieGRP · Traditional | 12/28/1982SE |
| K812434 | Diagnostic Kits & Kit ComponentsLHT · Traditional | 09/23/1981SE |
| K800398 | Paracontrol Abnormal Immunoglobulin ContDEW · Traditional | 03/12/1980SE |
| K791284 | Anti-Human Kappa SerumDFH · Traditional | 11/27/1979SE |
| K791283 | Anti-Human Lambda SerumDEH · Traditional | 11/27/1979SE |
| K791281 | Anti-Human Igg SerumDEW · Traditional | 11/27/1979SE |
| K791282 | Anti-Human SerumDGQ · Traditional | 10/17/1979SE |
| K790672 | Aspergillus Fumigatus, Aspergillus FlavuJWT · Traditional | 05/31/1979SE |
| K790671 | Dermatophytin OJXB · Traditional | 05/31/1979SE |
Questions and answers
When was Anti-Human Globulins cleared by the FDA?
Anti-Human Globulins (K791285) received a 510(k) decision of Substantially Equivalent on October 17, 1979, 99 days after the submission was received.
What is the product code of K791285?
The FDA product code is DEW – Igg, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.