Immunochemical Determination of Immunoglobulin G
FDA 510(k) K884074 · Orion Diagnostica, Inc.
510(k) numberK884074
Submission
- Device name
- Immunochemical Determination of Immunoglobulin G
- Applicant
- Orion Diagnostica, Inc.
02101 Espoo, FI - Received
- September 27, 1988
- Decision date
- October 27, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DAH – Gamma Globulin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code DAH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K931247 | Titan Gel IMMUNOFIX-9 Cat. No. 3051 and 3067DAH · Traditional | Helena Laboratories | 04/27/1993SE |
| K905149 | Titan GelDAH · Traditional | Helena Laboratories | 01/03/1991SE |
| K901805 | Rep(R) ImmunofixDAH · Traditional | Helena Laboratories | 06/06/1990SE |
| K883494 | Technicon DPA-1 Immunoglobulin GDAH · Traditional | Technicon Instruments Corp. | 09/07/1988SE |
| K854944 | TDX Immunoglobulin M Diagnostic KitDAH · Traditional | Abbott Laboratories | 08/27/1986SE |
| K862184 | Dako Ita, Immunoglobulin M (Igm)DAH · Traditional | Dako Corp. | 08/19/1986SE |
More from Dako Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and…DCK · Traditional | 03/10/2016SE |
| K043125 | Orion Diagnostica Uniq Pinp RiaCIN · Traditional | 05/04/2005SE |
| K042625 | Quikread CRP Calibrator SetJJY · Traditional | 11/18/2004SE |
| K042442 | Quickread System: Quickread CRP Kit, Model 06085; Quickread 101 Instrument, Model 06088…DCK · Special | 09/24/2004SE |
| K942286 | Diarlex Rota-AdenoLIQ · Traditional | 12/14/1994SE |
| K914892 | Saliva-StimEGD · Traditional | 09/02/1992SE |
| K904655 | PylorisetLYR · Traditional | 10/21/1991SE |
| K884147 | Immunochemical Determination of Immunoglobulin MDFT · Traditional | 10/27/1988SE |
| K884075 | Immunochemical Determination of TransferrinDDG · Traditional | 10/19/1988SE |
| K884040 | Immunochemical Determination of Immunoglobulin aCZP · Traditional | 10/19/1988SE |
Questions and answers
When was Immunochemical Determination of Immunoglobulin G cleared by the FDA?
Immunochemical Determination of Immunoglobulin G (K884074) received a 510(k) decision of Substantially Equivalent on October 27, 1988, 30 days after the submission was received.
What is the product code of K884074?
The FDA product code is DAH – Gamma Globulin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.