Raichem(Tm) Spia(Tm) Haptoglobin Reagent
FDA 510(k) K911898 · Reagents Applications, Inc.
510(k) numberK911898
Submission
- Device name
- Raichem(Tm) Spia(Tm) Haptoglobin Reagent
- Applicant
- Reagents Applications, Inc.
San Diego, CA, US - Received
- April 26, 1991
- Decision date
- May 8, 1991
- 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 |
|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K982056 | Raichem CO2 ReagentKHS · Special | 06/24/1998SE |
| K972853 | Cholesterol Rapid Liquid ReagentCHH · Traditional | 09/24/1997SE |
| K922904 | Rai-Trol Fructosamine Serum Controls I and IIJJX · Traditional | 07/30/1992SE |
| K915191 | Rai-Trol Elevated Lipids ControlJJY · Traditional | 12/18/1991SE |
| K913398 | Raichem(Tm) Creatine Kinase-Mb ReagentCGS · Traditional | 09/25/1991SE |
| K911900 | Raichem Spia C3 ReagentCZW · Traditional | 05/09/1991SE |
| K911899 | Raichem Spia C4 ReagentDBI · Traditional | 05/09/1991SE |
| K905085 | Raichem GGT ReagentJQB · Traditional | 12/20/1990SE |
| K905084 | Raichem Creatine Kinase Reagent, Optimized UVCGS · Traditional | 12/20/1990SE |
| K904175 | Raichem (TM) Spia (TM) - Acid Glycoprotein ReagentLKL · Traditional | 11/13/1990SE |
Questions and answers
When was Raichem(Tm) Spia(Tm) Haptoglobin Reagent cleared by the FDA?
Raichem(Tm) Spia(Tm) Haptoglobin Reagent (K911898) received a 510(k) decision of Substantially Equivalent on May 8, 1991, 12 days after the submission was received.
What is the product code of K911898?
The FDA product code is DAD – Haptoglobin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5460.