Spq(Tm) Antibody Reagent Set II for Igm
FDA 510(k) K890561 · Atlantic Antibodies
510(k) numberK890561
Submission
- Device name
- Spq(Tm) Antibody Reagent Set II for Igm
- Applicant
- Atlantic Antibodies
Scarborough, ME, US - Received
- January 24, 1989
- Decision date
- February 23, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CFQ – Radioimmunoassay, Immunoglobulins (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code CFQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K981786 | Iga Minineph AntiserumCFQ · Traditional | The Binding Site, Ltd. | 11/24/1999SE |
| K990552 | Immunoglobulin a Test SystemCFQ · Traditional | Dade Behring, Inc. | 03/25/1999SE |
| K990551 | Igg Flex Reagent CartridgeCFQ · Traditional | Dade Behring, Inc. | 03/25/1999SE |
| K990553 | Igm Flex Reagent CartridgeCFQ · Traditional | Dade Behring, Inc. | 03/22/1999SE |
| K951055 | Olympus Iga Immunoturbidimetric ReagentCFQ · Traditional | Olympus America, Inc. | 04/17/1995SE |
| K951013 | Olympus Igg Immunoturbidimetric ReagentCFQ · Traditional | Olympus America, Inc. | 04/17/1995SE |
| K950900 | Olympus Igm Immunoturbidimetric ReagentCFQ · Traditional | Olympus America, Inc. | 03/27/1995SE |
| K891188 | Titan Gel Ife Trivalent AntiserumCFQ · Traditional | Helena Laboratories | 03/22/1989SE |
| K881928 | Monoclonal Radial Immunodiffusion KitCFQ · Traditional | The Binding Site, Ltd. | 07/08/1988SE |
| K881827 | Immunoglobulin a Test SystemCFQ · Traditional | The Binding Site, Ltd. | 06/10/1988SE |
More from The Binding Site, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K892526 | SPQ TM Test System II for CRPDCK · Traditional | 05/09/1989SE |
| K891154 | Spq(Tm) Antibody Reagent Set II for Apo A-I/Apo BMSJ · Traditional | 03/16/1989SE |
| K890563 | Spq(Tm) Antibody Reagent Set II for TRFDDG · Traditional | 03/03/1989SE |
| K890562 | Spq(Tm) Antibody Reagent Set II for HPTDAD · Traditional | 02/22/1989SE |
| K890416 | Spq(Tm) Antibody Reagent Set II for IggDEW · Traditional | 02/22/1989SE |
| K890564 | Spq(Tm) Antibody Reagent Set II for C4DBI · Traditional | 02/17/1989SE |
| K890417 | Spq(Tm) Antibody Reagent Set II for C3KTQ · Traditional | 02/17/1989SE |
| K890415 | Spq(Tm) Antibody Reagent Set II for AatDEM · Traditional | 02/17/1989SE |
| K890560 | Spq(Tm) Antibody Reagent Set II for IgaCZP · Traditional | 02/15/1989SE |
| K884298 | Spq(Tm) Test System for MicroalbuminJZJ · Traditional | 11/02/1988SE |
Questions and answers
When was Spq(Tm) Antibody Reagent Set II for Igm cleared by the FDA?
Spq(Tm) Antibody Reagent Set II for Igm (K890561) received a 510(k) decision of Substantially Equivalent on February 23, 1989, 30 days after the submission was received.
What is the product code of K890561?
The FDA product code is CFQ – Radioimmunoassay, Immunoglobulins (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.