Kits, Ria, Myoglobin, Human, Measurement
FDA 510(k) K780982 · Cis Radiopharmaceuticals, Inc.
510(k) numberK780982
Submission
- Device name
- Kits, Ria, Myoglobin, Human, Measurement
- Applicant
- Cis Radiopharmaceuticals, Inc.
Mchenry, IL, US - Received
- June 14, 1978
- Decision date
- June 22, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DDR – Myoglobin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5680
- Specialty
- Immunology
Other 510(k)s with product code DDR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231832 | Access MyoglobinDDR · Traditional | Beckman Coulter, Inc. | 09/18/2023SE |
| K123785 | Diazyme Myoglobin; Assay, Calibrator Set, Control SetDDR · Traditional | Diazyme Laboratories | 06/07/2013SE |
| K122599 | Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin CalibratorDDR · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/03/2012SE |
| K083260 | Elecsys Myoglobin Stat, and Elecsys MyoglobinDDR · Traditional | Roche Diagnostics | 10/16/2009SE |
| K080481 | Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin CalibratorsDDR · Traditional | Beckman Coulter, Inc. | 02/20/2009SE |
| K061683 | Tina-Quant Myoglobin GEN.2 Test SystemDDR · Traditional | Roche Diagnostics Corp. | 07/21/2006SE |
| K042924 | Architect Stat Myo ImmunoassayDDR · Traditional | Fisher Diagnostics | 01/24/2005SE |
| K042982 | Quantex MyoglobinDDR · Traditional | Instrumentation Laboratory CO | 12/22/2004SE |
| K033300 | Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range VerifiersDDR · Traditional | Ortho-Clinical Diagnostics, Inc. | 11/05/2003SE |
| K021229 | Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model 973243…DDR · Traditional | Beckman Coulter, Inc. | 06/28/2002SE |
More from Beckman Coulter, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K791860 | Ferritin Ria KitDBF · Traditional | 12/06/1979SE |
| K792063 | Follicle Stimulating Hormone (FSH) KitCGJ · Traditional | 11/20/1979SE |
| K791202 | Ria Kit for TrypsinJNO · Traditional | 11/05/1979SE |
| K792000 | Luteinizing Hormone (LH) RiaCEP · Traditional | 10/30/1979SE |
| K791051 | Progesterone Radioimmunoassay KitJLS · Traditional | 07/24/1979SE |
| K790003 | Ria Kit, ProlactinCFT · Traditional | 03/12/1979SE |
| K771878 | Iridium 192 Wires & PinsIWA · Traditional | 10/27/1977SE |
| K760251 | Set, Oral AdministrationLEY · Traditional | 09/15/1976SE |
Questions and answers
When was Kits, Ria, Myoglobin, Human, Measurement cleared by the FDA?
Kits, Ria, Myoglobin, Human, Measurement (K780982) received a 510(k) decision of Substantially Equivalent on June 22, 1978, 8 days after the submission was received.
What is the product code of K780982?
The FDA product code is DDR – Myoglobin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5680.