DeviceClearance

HELENA VMA-SMC CONTROL— 510(k) K811912

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K811912 for HELENA VMA-SMC CONTROL, Substantially Equivalent on 1981-07-23. Applicant: Helena Laboratories.

Clearance details

Applicant
Helena Laboratories
Product code
Code JJX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JJX

product code JJX
Other
2
Total
2

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.