Quantimetric Plus Igm Reagent Kit
FDA 510(k) K855010 · Kallestad Laboratories, Inc.
510(k) numberK855010
Submission
- Device name
- Quantimetric Plus Igm Reagent Kit
- Applicant
- Kallestad Laboratories, Inc.
Chaska, MN, US - Received
- December 16, 1985
- Decision date
- February 28, 1986
- 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 |
| 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 |
More from Kallestad Diag, A Div. of Erbamont, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K863681 | Pathfinder(Tm) Direct Antigen Detection SystemLJP · Traditional | 12/03/1986SE |
| K862917 | Pathfinder Rotavirus ChemiluminescentLIQ · Traditional | 10/22/1986SE |
| K863682 | Pathfinder(Tm) Specimen Collection KitJSM · Traditional | 10/10/1986SE |
| K862743 | Pathfinder(Tm) Respiratory Syncytial VirusGQG · Traditional | 09/29/1986SE |
| K862313 | Kallestad Sm/Rnp Test ReagentLKJ · Traditional | 08/06/1986SE |
| K862710 | Kallestad Ssa/Ssb Ena Test ReagentsLLL · Traditional | 07/29/1986SE |
| K855014 | Quantimetric Plus Calibrator/Control Set aJIX · Traditional | 03/14/1986SE |
| K855013 | Quantimetric Plus Support PackDEH · Traditional | 02/26/1986SE |
| K855012 | Quantimetric Plus C4 Reagent KitDBI · Traditional | 02/26/1986SE |
| K855011 | Quantimetric Plus C3 Reagent KitCZN · Traditional | 02/26/1986SE |
Questions and answers
When was Quantimetric Plus Igm Reagent Kit cleared by the FDA?
Quantimetric Plus Igm Reagent Kit (K855010) received a 510(k) decision of Substantially Equivalent on February 28, 1986, 74 days after the submission was received.
What is the product code of K855010?
The FDA product code is DFT – Igm, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.