GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK— 510(k) K873577

Name: FDA 510(k) clearance K873577
Creator: U.S. Food and Drug Administration
Published: 1988-04-28

Substantially Equivalent

Diamond Sensor Systems

FDA 510(k) clearance K873577 for GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK, Substantially Equivalent on 1988-04-28. Applicant: Diamond Sensor Systems. Device class: 2.

Clearance details

Applicant: Diamond Sensor Systems
Product code: Code CHL
Device class: Class 2
Regulation: 21 CFR 862.1120
Advisory panel: Clinical Chemistry
Date received: 1987-09-03
Decision date: 1988-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Diamond Sensor Systems

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K882450 — GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.1988-07-28
K871686 — GEM-CRIT CHECK1987-06-18

Adverse events under product code CHL

product code CHL

Death: 20
Malfunction: 999
Total: 1,019

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.