REAGENT, RIA TRIIODOTHYRONINE T3 (#200)— 510(k) K760078

Substantially Equivalent

Oxford Laboratories, Inc.

FDA 510(k) clearance K760078 for REAGENT, RIA TRIIODOTHYRONINE T3 (#200), Substantially Equivalent on 1976-07-20. Applicant: Oxford Laboratories, Inc..

Clearance details

Applicant
Oxford Laboratories, Inc.
Product code
Code CDP
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 CDP

product code CDP
Malfunction
647
Total
647

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.