Cardiac Status, Lifesign Mi, Vitalsign, Accusign Ck-Mb/Myoglobin
FDA 510(k) K952360 · Princeton BioMeditech Corp.
510(k) numberK952360
Submission
- Device name
- Cardiac Status, Lifesign Mi, Vitalsign, Accusign Ck-Mb/Myoglobin
- Applicant
- Princeton BioMeditech Corp.
Monmouth Junction, NJ, US - Received
- May 3, 1995
- Decision date
- August 14, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DDR – Myoglobin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5680
- Specialty
- Immunology
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|---|---|---|---|
| K231832 | Access MyoglobinDDR · Traditional | Beckman Coulter, Inc. | 09/18/2023SE |
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| 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 |
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Questions and answers
When was Cardiac Status, Lifesign Mi, Vitalsign, Accusign Ck-Mb/Myoglobin cleared by the FDA?
Cardiac Status, Lifesign Mi, Vitalsign, Accusign Ck-Mb/Myoglobin (K952360) received a 510(k) decision of Substantially Equivalent on August 14, 1995, 103 days after the submission was received.
What is the product code of K952360?
The FDA product code is DDR – Myoglobin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5680.