VACUPLUS TUBES WITH GREEN STOPPERS— 510(k) K924361

Substantially Equivalent

Starplex Scientific, Inc.

FDA 510(k) clearance K924361 for VACUPLUS TUBES WITH GREEN STOPPERS, Substantially Equivalent on 1993-03-01. Applicant: Starplex Scientific, Inc..

Clearance details

Applicant
Starplex Scientific, Inc.
Product code
Code JKA
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Etobicoke, Ontario, CA
Download summary PDFView on FDA.gov ↗

Adverse events under product code JKA

product code JKA
Injury
455
Malfunction
26,686
Other
4
Total
27,145

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.