Igm Immunotrubidimetric & Calibrator
FDA 510(k) K955797 · Randox Laboratories, Ltd.
510(k) numberK955797
Submission
- Device name
- Igm Immunotrubidimetric & Calibrator
- Applicant
- Randox Laboratories, Ltd.
Crumlin, IE - Received
- December 22, 1995
- Decision date
- April 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K884147 | Immunochemical Determination of Immunoglobulin MDFT · Traditional | Orion Diagnostica, Inc. | 10/27/1988SE |
| 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 |
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Questions and answers
When was Igm Immunotrubidimetric & Calibrator cleared by the FDA?
Igm Immunotrubidimetric & Calibrator (K955797) received a 510(k) decision of Substantially Equivalent on April 5, 1996, 105 days after the submission was received.
What is the product code of K955797?
The FDA product code is DFT – Igm, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.