Immunochemical Determination of Immunoglobulin M
FDA 510(k) K884147 · Orion Diagnostica, Inc.
510(k) numberK884147
Submission
- Device name
- Immunochemical Determination of Immunoglobulin M
- Applicant
- Orion Diagnostica, Inc.
02101 Espoo, FI - Received
- October 3, 1988
- Decision date
- October 27, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DFT – Igm, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
Other 510(k)s with product code DFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983132 | IgmDFT · Traditional | Abbott Laboratories | 11/04/1998SE |
| K962201 | Quantex IgmDFT · Traditional | Instrumentation Laboratory CO | 09/25/1996SE |
| K955797 | Igm Immunotrubidimetric & CalibratorDFT · Traditional | Randox Laboratories, Ltd. | 04/05/1996SE |
| K945522 | I.D.-Zone Immunofixation Electrophoresis ControlsDFT · Traditional | Beckman-Diagnostic Systems Group | 12/12/1994SE |
| K901453 | Quik-Sep(R) Igm Rprotein G Affinity MethodDFT · Traditional | Isolab, Inc. | 04/12/1990SE |
| K894417 | Raichem(Tm) Spia(Tm) Igm ReagentsDFT · Traditional | Reagents Applications, Inc. | 08/02/1989SE |
| K880828 | Wako(Tm) Igm-Ha DirectDFT · Traditional | Wako Chemicals USA, Inc. | 03/25/1988SE |
| K873871 | Immunoglobulins MDFT · Traditional | Unipath , Ltd. | 10/13/1987SE |
| K872237 | Kallestad QM300 Igm Antibody PackDFT · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 07/09/1987SE |
| K871498 | Titan Gel Immunofix ControlsDFT · Traditional | Helena Laboratories | 04/29/1987SE |
More from Helena Laboratories
| 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 |
| K884074 | Immunochemical Determination of Immunoglobulin GDAH · 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 M cleared by the FDA?
Immunochemical Determination of Immunoglobulin M (K884147) received a 510(k) decision of Substantially Equivalent on October 27, 1988, 24 days after the submission was received.
What is the product code of K884147?
The FDA product code is DFT – Igm, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.