Spq(Tm) Antibody Reagent Set II for Iga
FDA 510(k) K890560 · Atlantic Antibodies
510(k) numberK890560
Submission
- Device name
- Spq(Tm) Antibody Reagent Set II for Iga
- Applicant
- Atlantic Antibodies
Scarborough, ME, US - Received
- January 24, 1989
- Decision date
- February 15, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CZP – Iga, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code CZP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…CZP · Traditional | Horiba Abx SAS | 06/26/2020SE |
| K060130 | Immage Systems Low Concentration Immunoglobulin a ReagentCZP · Special | Beckman Coulter, Inc. | 02/13/2006SE |
| K040435 | Roche Diagnostics Tina-Quant Iga GEN.2CZP · Special | Roche Diagnostics Corp. | 03/10/2004SE |
| K024038 | N Latex IgaCZP · Traditional | Dade Behring, Inc. | 02/13/2003SE |
| K993927 | Wako Iga Ii-Ha, Immunoglobulin Calibrator Set, Immunoglobulin StandradCZP · Traditional | Wako Chemicals USA, Inc. | 01/14/2000SE |
| K983359 | IgaCZP · Traditional | Abbott Laboratories | 11/04/1998SE |
| K962200 | Quantex IgaCZP · Traditional | Instrumentation Laboratory CO | 09/25/1996SE |
| K955794 | Iga Immunoturbidimetric & CalibratorCZP · Traditional | Randox Laboratories, Ltd. | 04/05/1996SE |
| K955907 | Boehringer Mannheim Iga AssayCZP · Traditional | Boehringer Mannheim Corp. | 02/09/1996SE |
| K952309 | N Latex IgaCZP · Traditional | Behring Diagnostics, Inc. | 06/20/1995SE |
More from Behring Diagnostics, Inc.
| 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 |
| K890561 | Spq(Tm) Antibody Reagent Set II for IgmCFQ · Traditional | 02/23/1989SE |
| 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 |
| K884298 | Spq(Tm) Test System for MicroalbuminJZJ · Traditional | 11/02/1988SE |
Questions and answers
When was Spq(Tm) Antibody Reagent Set II for Iga cleared by the FDA?
Spq(Tm) Antibody Reagent Set II for Iga (K890560) received a 510(k) decision of Substantially Equivalent on February 15, 1989, 22 days after the submission was received.
What is the product code of K890560?
The FDA product code is CZP – Iga, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.