SYNERGY QUAD— 510(k) K941443

Name: FDA 510(k) clearance K941443
Creator: U.S. Food and Drug Administration
Published: 1994-09-19

Substantially Equivalent

Remel Co.

FDA 510(k) clearance K941443 for SYNERGY QUAD, Substantially Equivalent on 1994-09-19. Applicant: Remel Co.. Device class: 2.

Clearance details

Applicant: Remel Co.
Product code: Code JSO
Device class: Class 2
Regulation: 21 CFR 866.1700
Advisory panel: Microbiology
Date received: 1994-03-24
Decision date: 1994-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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K171061 — MRSASelect II2017-12-28
K162620 — Remel Spectra ESBL2017-05-01
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Adverse events under product code JSO

product code JSO

Malfunction: 602
Total: 602

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.