Stratus CS Myoglobin (Myo) Testpak
FDA 510(k) K981102 · Dade Behring, Inc.
510(k) numberK981102
Submission
- Device name
- Stratus CS Myoglobin (Myo) Testpak
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- March 26, 1998
- Decision date
- April 27, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 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 Stratus CS Myoglobin (Myo) Testpak cleared by the FDA?
Stratus CS Myoglobin (Myo) Testpak (K981102) received a 510(k) decision of Substantially Equivalent on April 27, 1998, 32 days after the submission was received.
What is the product code of K981102?
The FDA product code is DDR – Myoglobin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5680.