Panels › Immunology › Product code DDR · Class 2
Myoglobin, Antigen, Antiserum, Control
Regulation 866.5680
0510(k)s in 12 months (46 all time)
0recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in DDR
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter, Inc. | 4 | 1 |
| Dade Behring, Inc. | 3 | 2 |
| Abbott Laboratories | 1 | 3 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 3 |
| Behring Diagnostics, Inc. | 3 | 0 |
| Diagnostic Products Corp. | 3 | 0 |
| Baxter Diagnostics, Inc. | 2 | 0 |
| Boehringer Mannheim Corp. | 2 | 0 |
| Immuno Diagnostic Center, Inc. | 2 | 0 |
| Roche Diagnostics | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2024 | Abbott Laboratories ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. Open, Classified |
DDR | K042924 |
| Jul 2, 2019 | Roche Diagnostics Operations, Inc. The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry a Terminated |
DDR | K061683 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK Myoglobin; Part Number: 025297
Assay, Cardiac Marker Terminated |
DDR | K981012 |
| Aug 8, 2016 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Calibrator U,
For in vitro diagnostic use in calibrating the following assays using
ADVIA Centaur"' systems: Myoglobin cTnl
Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 Terminated |
DDR | K122599 |
| Jan 7, 2016 | Siemens Healthcare Diagnostics Inc Siemens Acute Care MYO DilPak
Catalog Number: CMYO-D
SMN:10445081
in vitro diagnostic Terminated |
DDR | K051650 |
| Jan 7, 2016 | Siemens Healthcare Diagnostics Inc Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma
Catalog Number: CMYO
SMN:10445079 Terminated |
DDR | K051650 |
| May 22, 2009 | Beckman Coulter Inc Access Myoglobin Reagents Kits, Part Number: 973243.
The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Myoglobin levels in huma Terminated |
DDR | K021229 |
| Apr 15, 2009 | Abbott Laboratories AxSYM Myoglobin Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM Myoglobin is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of myoglobin in human serum or Terminated |
DDR | K983848 |
| Jul 11, 2007 | Abbott Laboratories AxSYM Myoglobin Reagent Pack; list 03E43; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
DDR | K983848 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer MYO DilPak (CMYO-D) in vitro diagnostic. Terminated |
DDR | K984065 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer MYO TestPak (CMYO) in vitro diagnostic. Terminated |
DDR | K984065 |
| Jan 18, 2006 | Abbott Laboratories MPG ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
DDR | K042920 |
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