PROTOPORPHYRIN ZN CONTROL— 510(k) K830493

Substantially Equivalent

Kaulson Laboratories, Inc.

FDA 510(k) clearance K830493 for PROTOPORPHYRIN ZN CONTROL, Substantially Equivalent on 1983-04-18. Applicant: Kaulson Laboratories, Inc..

Clearance details

Applicant: Kaulson Laboratories, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1983-02-16
Decision date: 1983-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.