Diffu-Gen Haptoglobin Radial Immuno
FDA 510(k) K840404 · Tago, Inc.
510(k) numberK840404
Submission
- Device name
- Diffu-Gen Haptoglobin Radial Immuno
- Applicant
- Tago, Inc.
Mchenry, IL, US - Received
- January 31, 1984
- Decision date
- March 9, 1984
- 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 |
|---|---|---|
| K841734 | Tago Fiffu-Gen, OrosomucoidLKL · Traditional | 06/01/1984SE |
| K841265 | Tago Diffu-Gen C-Reactive ProteinDCN · Traditional | 05/22/1984SE |
| K834218 | Diffu-Gen Apolipoprotein A-I Radial -MSJ · Traditional | 05/11/1984SE |
| K833129 | Tago Diffu-Gen-Apolipoprotein B-100MSJ · Traditional | 11/21/1983SE |
| K830611 | Ra Screening TestDHR · Traditional | 03/24/1983SE |
| K830531 | Mono Screening TestKTN · Traditional | 03/17/1983SE |
| K830156 | HCG Screening TestJHJ · Traditional | 02/09/1983SE |
Questions and answers
When was Diffu-Gen Haptoglobin Radial Immuno cleared by the FDA?
Diffu-Gen Haptoglobin Radial Immuno (K840404) received a 510(k) decision of Substantially Equivalent on March 9, 1984, 38 days after the submission was received.
What is the product code of K840404?
The FDA product code is DAD – Haptoglobin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5460.