ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS— 510(k) K052407
Substantially EquivalentFisher Diagnostics
FDA 510(k) clearance K052407 for ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS, Substantially Equivalent on 2006-07-18. Applicant: Fisher Diagnostics. Device class: 2.
Clearance details
- Applicant
- Fisher Diagnostics
- Product code
- Code JZO
- Device class
- Class 2
- Regulation
- 21 CFR 866.5870
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Middletown, VA, US
Recent devices under product code JZO
view allMore clearances from Fisher Diagnostics
view all- K170652 — ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls
- K070640 — ARCHITECT STAT TROPONIN-1; MYOGLOBIN
- K052308 — ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
- K042924 — ARCHITECT STAT MYO IMMUNOASSAY
- K041192 — ARCHITECT STAT TROPONIN-I IMMUNOASSAY
Recalls naming K052407
K-number listed on FDA's recall record- Z-1843-2025 — ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
- Z-1696-2023 — Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052407.
Data sourced from openFDA. This site is unofficial and independent of the FDA.