SPECIMEN COLLECTORS— 510(k) K822005

Name: FDA 510(k) clearance K822005
Creator: U.S. Food and Drug Administration
Published: 1982-07-28

Substantially Equivalent

Kelleher Corp.

FDA 510(k) clearance K822005 for SPECIMEN COLLECTORS, Substantially Equivalent on 1982-07-28. Applicant: Kelleher Corp.. Device class: 2.

Clearance details

Applicant: Kelleher Corp.
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1982-07-08
Decision date: 1982-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Kelleher Corp.

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K822268 — NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH1983-01-28
K822618 — EMERGENCY TRACHEOSTOMY INSTRUMENT SET1983-01-28
K823083 — ELECTROSURGICAL UNIT1982-12-07
K822252 — ENT TREATMENT UNITS1982-11-22
K823111 — NYSTYMOGRAPH ACCESS1982-11-22

Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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.