K-Assay Haptoglobin
FDA 510(k) K993480 · Kamiya Biomedical Co.
510(k) numberK993480
Submission
- Device name
- K-Assay Haptoglobin
- Applicant
- Kamiya Biomedical Co.
Seattle, WA, US - Received
- October 14, 1999
- Decision date
- November 24, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
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| K192727 | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)DHR · Traditional | 05/20/2020SE |
| K121232 | K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin CalibratorDBF · Traditional | 05/24/2012SE |
| K093137 | K-Assay Cystatin C Reagent, Calibrator and ControlNDY · Traditional | 09/28/2010SE |
| K091486 | K-Assay Microalbumin and K-Assay Microalbumin CalibratorDCF · Traditional | 04/29/2010SE |
| K050944 | K-Assay Ferritin (2) & Ferritin Calibrator SetDBF · Traditional | 12/23/2005SE |
| K042241 | K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093CDGC · Traditional | 12/10/2004SE |
| K030687 | K-Assay D-Dimer, K-Assay D-Dimer Calibrator, Models KAI-090; KAJ-091CDAP · Traditional | 06/27/2003SE |
| K023828 | K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP…DCK · Traditional | 02/04/2003SE |
| K023853 | K-Assay Lp(A) ControlsDFC · Traditional | 12/13/2002SE |
Questions and answers
When was K-Assay Haptoglobin cleared by the FDA?
K-Assay Haptoglobin (K993480) received a 510(k) decision of Substantially Equivalent on November 24, 1999, 41 days after the submission was received.
What is the product code of K993480?
The FDA product code is DAD – Haptoglobin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5460.