Spq(Tm) Antibody Reagent Set II for HPT
FDA 510(k) K890562 · Atlantic Antibodies
510(k) numberK890562
Submission
- Device name
- Spq(Tm) Antibody Reagent Set II for HPT
- Applicant
- Atlantic Antibodies
Scarborough, ME, US - Received
- January 24, 1989
- Decision date
- February 22, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DAD – Haptoglobin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5460
- Specialty
- Immunology
Other 510(k)s with product code DAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993480 | K-Assay HaptoglobinDAD · Traditional | Kamiya Biomedical Co. | 11/24/1999SE |
| K972639 | Tina-Quant HaptoglobinDAD · Traditional | Boehringer Mannheim Corp. | 01/09/1998SE |
| K964301 | N-Assay Tia Multi V-NlDAD · Traditional | Crestat Diagnostics, Inc. | 07/14/1997SE |
| K963286 | Immage Immunochemistry System Haptoglobin (HPT) ReagentDAD · Traditional | Beckman Instruments, Inc. | 10/07/1996SE |
| K952593 | N/T Protein Control Sy/L, M and HDAD · Traditional | Behring Diagnostics, Inc. | 07/17/1995SE |
| K915829 | Il Test(Tm) Haptoglobin (HPT)DAD · Traditional | Instrumentation Laboratory CO | 07/29/1992SE |
| K911898 | Raichem(Tm) Spia(Tm) Haptoglobin ReagentDAD · Traditional | Reagents Applications, Inc. | 05/08/1991SE |
| K873866 | HaptoglobinDAD · Traditional | Unipath , Ltd. | 10/20/1987SE |
| K872717 | QM300 Haptoglobin Antibody PackDAD · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 07/21/1987SE |
| K864512 | Immuno-Plate IV Radial Immuno Test Kit/Human HaptoDAD · Traditional | Cooper Biomedical, Inc. | 02/13/1987SE |
More from Cooper Biomedical, 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 |
| 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 HPT cleared by the FDA?
Spq(Tm) Antibody Reagent Set II for HPT (K890562) received a 510(k) decision of Substantially Equivalent on February 22, 1989, 29 days after the submission was received.
What is the product code of K890562?
The FDA product code is DAD – Haptoglobin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5460.