ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040— 510(k) K860453

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K860453 for ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040, Substantially Equivalent on 1986-02-19. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1986-02-05
Decision date: 1986-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.