ARCHITECT STAT MYO IMMUNOASSAY— 510(k) K042924
Substantially EquivalentFisher Diagnostics
FDA 510(k) clearance K042924 for ARCHITECT STAT MYO IMMUNOASSAY, Substantially Equivalent on 2005-01-24. Applicant: Fisher Diagnostics. Device class: 2.
Clearance details
- Applicant
- Fisher Diagnostics
- Product code
- Code DDR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5680
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Middletown, VA, US
Recent devices under product code DDR
view all- K231832 — Access Myoglobin
- K123785 — DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET
- K122599 — ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
- K083260 — ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
- K080481 — ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS
More 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
- K052407 — ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
- K052308 — ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
- K041192 — ARCHITECT STAT TROPONIN-I IMMUNOASSAY
Recalls naming K042924
K-number listed on FDA's recall record- Z-1476-2024 — ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
- Z-0891-2022 — ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042924.
Data sourced from openFDA. This site is unofficial and independent of the FDA.