ENZYMUN-TEST HCG— 510(k) K862108

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K862108 for ENZYMUN-TEST HCG, Substantially Equivalent on 1986-08-19. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code DHA
Advisory panel: Clinical Chemistry
Date received: 1986-06-03
Decision date: 1986-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DHA

product code DHA

Malfunction: 1,242
Total: 1,242

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.