OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376— 510(k) K926222
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K926222 for OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376, Substantially Equivalent on 1993-02-12. Applicant: Helena Laboratories. Device class: 2.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code JPA
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
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- K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
Adverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.