AUTO DELFIA— 510(k) K935047
Substantially EquivalentWallac OY
FDA 510(k) clearance K935047 for AUTO DELFIA, Substantially Equivalent on 1994-05-23. Applicant: Wallac OY. Device class: 1.
Clearance details
- Applicant
- Wallac OY
- Product code
- Code KHO
- Device class
- Class 1
- Regulation
- 21 CFR 862.2560
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Finland, FI
Recent devices under product code KHO
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view all- DEN140010 — PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
- K131284 — GSP NEONATAL BIOTINIDASE KIT
- K100682 — GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
- K081922 — AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
- K071649 — NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B
Adverse events under product code KHO
product code KHO- Malfunction
- 1,339
- Total
- 1,339
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K935047
K-number listed on FDA's recall record- Z-1100-2017 — AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry
- Z-1101-2017 — Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry
- Z-1102-2017 — DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K935047.
Data sourced from openFDA. This site is unofficial and independent of the FDA.