QM300 Haptoglobin Antibody Pack
FDA 510(k) K872717 · Kallestad Diag, A Div. of Erbamont, Inc.
510(k) numberK872717
Submission
- Device name
- QM300 Haptoglobin Antibody Pack
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
Chaska, MN, US - Received
- July 10, 1987
- Decision date
- July 21, 1987
- 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 |
| 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 |
|---|---|---|
| K910887 | QM300 Control G PackGTQ · Traditional | 06/17/1991SE |
| K910886 | QM300 Antistreptolysin O (Aso) Antigen PackGTQ · Traditional | 06/17/1991SE |
| K910885 | QM300 Calibrator G PackGTQ · Traditional | 06/17/1991SE |
| K904725 | Chlamydia System Software (CSS)LJC · Traditional | 01/14/1991SE |
| K902253 | Pathfinder(Tm) Chlamydia Microplate KitLJC · Traditional | 07/26/1990SE |
| K902462 | Modified QM300 Rheumatoid Factor TestDHR · Traditional | 06/21/1990SE |
| K900010 | NDS Cortisol Test Kit and NDS Cortisol CalibratorJFT · Traditional | 04/03/1990SE |
| K900009 | NDS Theophylline Test Kit & NDS TDM Calibrator SetKLS · Traditional | 03/29/1990SE |
| K897072 | NDS Thyroxine Test Kit & NDS Thyroxine CalibratorKLI · Traditional | 03/29/1990SE |
| K894947 | Platelia Toxo Igg KitLGO · Traditional | 03/23/1990SE |
Questions and answers
When was QM300 Haptoglobin Antibody Pack cleared by the FDA?
QM300 Haptoglobin Antibody Pack (K872717) received a 510(k) decision of Substantially Equivalent on July 21, 1987, 11 days after the submission was received.
What is the product code of K872717?
The FDA product code is DAD – Haptoglobin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5460.