MICROSTAT 2— 510(k) K984485

Name: FDA 510(k) clearance K984485
Creator: U.S. Food and Drug Administration
Published: 1999-01-13

Substantially Equivalent

Chemlink Laboratories, LLC

FDA 510(k) clearance K984485 for MICROSTAT 2, Substantially Equivalent on 1999-01-13. Applicant: Chemlink Laboratories, LLC. Device class: 1.

Clearance details

Applicant: Chemlink Laboratories, LLC
Product code: Code LRJ
Device class: Class 1
Regulation: 21 CFR 880.6890
Advisory panel: General Hospital
Date received: 1998-12-17
Decision date: 1999-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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K991509 — PRO-PORTION CLEANER/DISINFECTANT1999-07-14
K983947 — AMERSE 21998-12-04
K983869 — DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH1998-11-30
K983585 — LOW PH PHENOLIC 2561998-11-06

Adverse events under product code LRJ

product code LRJ

Injury: 958
Total: 958

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.