DeviceClearance

Product code GIM— Clinical Chemistry

1400 SERIES EVIDENCE COLLECTION KIT

Classification name
Tubes, Vacuum Sample, With Anticoagulant
Device class
Class 2
Regulation
21 CFR 862.1675
Advisory panel
Clinical Chemistry
Total cleared
39
First cleared
Most recent

Market context for product code GIM

FDA has cleared 39 devices under product code GIM between 1976 and 2024, filed by 24 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code GIM

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 →

Recent clearances under product code GIM

Data sourced from openFDA. This site is unofficial and independent of the FDA.