ISE/NA+— 510(k) K912648

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K912648 for ISE/NA+, Substantially Equivalent on 1991-07-17. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 1991-06-17
Decision date: 1991-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

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.