SPQ Test System for Haptoglobin
FDA 510(k) K850584 · Applications Lab
510(k) numberK850584
Submission
- Device name
- SPQ Test System for Haptoglobin
- Applicant
- Applications Lab
Scarborough, ME, US - Received
- February 13, 1985
- Decision date
- March 5, 1985
- 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 |
| K890562 | Spq(Tm) Antibody Reagent Set II for HPTDAD · Traditional | Atlantic Antibodies | 02/22/1989SE |
| K873866 | HaptoglobinDAD · Traditional | Unipath , Ltd. | 10/20/1987SE |
| K872717 | QM300 Haptoglobin Antibody PackDAD · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 07/21/1987SE |
More from Kallestad Diag, A Div. of Erbamont, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K850587 | SPQ Test System for Alpha, - AntitrypsinDEM · Traditional | 03/14/1985SE |
| K850586 | SPQ Test System for Immunoglobulin MDAO · Traditional | 03/14/1985SE |
| K850603 | SPQ Test System for ALPHA(2) MacroglobulinDEB · Traditional | 03/05/1985SE |
| K850589 | SPQ Test System for TransferrinDDG · Traditional | 03/05/1985SE |
| K850588 | SPQ Test System for Complement C3CZW · Traditional | 03/05/1985SE |
| K850590 | SPQ Test System for C-Reactive ProteinDCK · Traditional | 03/01/1985SE |
| K850585 | SPQ Test System for Complement C4DBI · Traditional | 03/01/1985SE |
| K850583 | SPQ Test System for Immunoglobulin GDEW · Traditional | 03/01/1985SE |
| K850582 | SPQ Test System for Immunoglobulin aCZP · Traditional | 03/01/1985SE |
Questions and answers
When was SPQ Test System for Haptoglobin cleared by the FDA?
SPQ Test System for Haptoglobin (K850584) received a 510(k) decision of Substantially Equivalent on March 5, 1985, 20 days after the submission was received.
What is the product code of K850584?
The FDA product code is DAD – Haptoglobin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5460.