BLOOD COLLECTION TUBE, RED— 510(k) K771055

Substantially Equivalent

Sherwood Medical Industries

FDA 510(k) clearance K771055 for BLOOD COLLECTION TUBE, RED, Substantially Equivalent on 1977-06-29. Applicant: Sherwood Medical Industries. Device class: 2.

Clearance details

Applicant
Sherwood Medical Industries
Product code
Code GIM
Device class
Class 2
Regulation
21 CFR 862.1675
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GIM

product code GIM
Malfunction
1,325
Total
1,325

Source: openFDA MAUDE database, through . 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.