LANCET, BLOOD— 510(k) K883420

Substantially Equivalent

Primrose Medical, Inc.

FDA 510(k) clearance K883420 for LANCET, BLOOD, Substantially Equivalent on 1988-08-26. Applicant: Primrose Medical, Inc..

Clearance details

Applicant: Primrose Medical, Inc.
Product code: Code FMK
Advisory panel: General, Plastic Surgery
Date received: 1988-08-15
Decision date: 1988-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.