FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTEX MYOGLOBIN
K Number: K042982
·
Decision Dec 22, 2004
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
45
Applicant Total
321
Review Days
54
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- QUANTEX MYOGLOBIN
- K Number
- K042982
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5680
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentation Laboratory CO
- Date Received
- October 29, 2004
- Decision Date
- December 22, 2004
- Product Code
- DDR
- Advisory Committee
- Immunology
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DDR | Myoglobin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DDR), ordered by most recent decision date.
Access Myoglobin
FDA 510(k)
FDA Class 2
·Immunology
DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET
FDA 510(k)
FDA Class 2
·Immunology
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
FDA 510(k)
FDA Class 2
·Immunology
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
FDA 510(k)
FDA Class 2
·Immunology
ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS
FDA 510(k)
FDA Class 2
·Immunology
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Instrumentation Laboratory CO
| K Number | Device Name | ||
|---|---|---|---|
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM | Sep 29, 2023 | Substantially Equivalent |
| K223187 | HemosIL Liquid Anti-Xa | Jun 23, 2023 | Substantially Equivalent |
| K223090 | GEM Premier ChemSTAT | Jan 27, 2023 | Substantially Equivalent |
| K223402 | HemosIL von Willebrand Factor Antigen | Dec 9, 2022 | Substantially Equivalent |
| K213464 | HemosIL Liquid Anti-Xa | Oct 4, 2022 | Substantially Equivalent |
| K213426 | HemosIL ReadiPlasTin | Aug 16, 2022 | Substantially Equivalent |
| K203790 | GEM Premier 5000 | Aug 20, 2021 | Substantially Equivalent |
| DEN190032 | HemosIL Liquid Anti-Xa | Sep 17, 2020 | Unknown |
| K200033 | HemosIL von Willebrand Factor Antigen | Aug 19, 2020 | Substantially Equivalent |
| K183549 | GEM Premier ChemSTAT | Feb 16, 2019 | Substantially Equivalent |