HISTO-TEK W/ AUTOMATIC COVERSLIPPER— 510(k) K761062

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K761062 for HISTO-TEK W/ AUTOMATIC COVERSLIPPER, Substantially Equivalent on 1977-03-07. Applicant: Miles Laboratories, Inc..

Clearance details

Applicant
Miles Laboratories, Inc.
Product code
Code IEO
Advisory panel
Pathology
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 IEO

product code IEO
Injury
326
Total
326

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.