Quik-Sep(R) Igm Rprotein G Affinity Method
FDA 510(k) K901453 · Isolab, Inc.
510(k) numberK901453
Submission
- Device name
- Quik-Sep(R) Igm Rprotein G Affinity Method
- Applicant
- Isolab, Inc.
Akron, OH, US - Received
- March 27, 1990
- Decision date
- April 12, 1990
- 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 |
| 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 |
More from Helena Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K951014 | Isolab's T4 Test KitKLI · Traditional | 10/18/1996SE |
| K950481 | Neonatal Chemistry System, Galactose Test KitJIA · Traditional | 02/01/1996SE |
| K943547 | Phenylalanine Test KitJNB · Traditional | 01/26/1996SE |
| K950803 | Isolab's GALACTOSE-1-PHOSPHATE Uridyl Tranferase Test Kits 800, 4000 SampleJJT · Traditional | 09/21/1995SE |
| K950415 | Fluoroscan NeonatalKHO · Traditional | 09/05/1995SE |
| K942276 | Quik-Sep Quantitative Hemoglobin S AssayGIQ · Traditional | 01/20/1995SE |
| K942222 | Quik-Sep Quantitive Hemoglobin S ControlsJCM · Traditional | 01/20/1995SE |
| K944185 | IsoscanJQT · Traditional | 11/17/1994SE |
| K934013 | Resolve Systems Alkaline Phosphatase Test KitCIN · Traditional | 04/26/1994SE |
| K923153 | Hemocard, Hemoglobin C AssayMLL · Traditional | 01/27/1994SE |
Questions and answers
When was Quik-Sep(R) Igm Rprotein G Affinity Method cleared by the FDA?
Quik-Sep(R) Igm Rprotein G Affinity Method (K901453) received a 510(k) decision of Substantially Equivalent on April 12, 1990, 16 days after the submission was received.
What is the product code of K901453?
The FDA product code is DFT – Igm, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.