KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION— 510(k) K936138

Substantially Equivalent

Eastman Kodak Company

FDA 510(k) clearance K936138 for KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION, Substantially Equivalent on 1994-04-08. Applicant: Eastman Kodak Company.

Clearance details

Applicant: Eastman Kodak Company
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1993-12-23
Decision date: 1994-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

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.