NEONATAL BLOOD COLLECTION AND SCREENING FORM— 510(k) K944618

Substantially Equivalent

General Business Forms, Inc.

FDA 510(k) clearance K944618 for NEONATAL BLOOD COLLECTION AND SCREENING FORM, Substantially Equivalent on 1995-05-10. Applicant: General Business Forms, Inc..

Clearance details

Applicant: General Business Forms, Inc.
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 1994-09-20
Decision date: 1995-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.