FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control
K Number: K191578
·
Decision Jul 17, 2019
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
3
Applicant Total
152
Review Days
33
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Basic Information
- Device Name
- ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control
- K Number
- K191578
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3935
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date Received
- June 14, 2019
- Decision Date
- July 17, 2019
- Product Code
- QFO
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| QFO | Zika Virus Serological Reagents | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QFO), ordered by most recent decision date.
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LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
FDA 510(k)
FDA Class 2
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ZIKV Detect 2.0 IgM Capture ELISA
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Siemens Healthcare Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K251630 | Atellica IM Total PSA II (tPSAII) | Jan 5, 2026 | Substantially Equivalent |
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Dec 4, 2025 | Substantially Equivalent |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | Oct 17, 2025 | Substantially Equivalent |
| K242981 | Atellica IM Thyroglobulin (Tg) | Jun 20, 2025 | Substantially Equivalent |
| K242685 | Atellica® CH Creatinine_3 (Crea3) | Dec 4, 2024 | Substantially Equivalent |
| K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) | Jul 26, 2024 | Substantially Equivalent |
| K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH) | Jul 25, 2024 | Substantially Equivalent |
| K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | Apr 4, 2024 | Substantially Equivalent |