Lifesign Mi Myoglobin
FDA 510(k) K942052 · Princeton Biomedix
510(k) numberK942052
Submission
- Device name
- Lifesign Mi Myoglobin
- Applicant
- Princeton Biomedix
Princeton, NJ, US - Received
- April 28, 1994
- Decision date
- February 7, 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
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 |
|---|---|---|
| K925355 | Biosign(Tm_ Rubella - Rubella Antibody TestLFX · Traditional | 07/12/1994SE |
| K930185 | Ovusign Lh/Conception Plus/Ovudate LH One-StepCEP · Traditional | 03/04/1993SE |
| K925183 | Biosign(Tm) Mono-Infect Mono Hetero Antibody TestKTN · Traditional | 02/23/1993SE |
| K926308 | Lifesign HCG - One Step Home Pregnancy TestLCX · Traditional | 01/26/1993SE |
| K901011 | Biosign Hcg-One Step Pregnancy TestJHI · Traditional | 05/04/1990SE |
| K894750 | Biostix I. HCG - One Step Pregnancy TestJHI · Traditional | 10/18/1989SE |
| K894705 | Biospot Hcg-Rapid Pregnancy TestJHI · Traditional | 10/18/1989SE |
| K892654 | Biostix (Tm)Hcg--Simple Pregnancy TestDHA · Traditional | 06/19/1989SE |
| K761315 | Alkaline Phosphatase (Alp)/PnppCJE · Traditional | 02/24/1977SE |
| K760346 | Assay for Gamma GlutamyltransferaseJPZ · Traditional | 10/27/1976SE |
Questions and answers
When was Lifesign Mi Myoglobin cleared by the FDA?
Lifesign Mi Myoglobin (K942052) received a 510(k) decision of Substantially Equivalent on February 7, 1995, 285 days after the submission was received.
What is the product code of K942052?
The FDA product code is DDR – Myoglobin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5680.