MEDI-TEST COMBI 11— 510(k) K991927

Substantially Equivalent

Macherey-Nagel-Duren

FDA 510(k) clearance K991927 for MEDI-TEST COMBI 11, Substantially Equivalent on 1999-09-17. Applicant: Macherey-Nagel-Duren. Device class: 2.

Clearance details

Applicant: Macherey-Nagel-Duren
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 1999-06-08
Decision date: 1999-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K991927

K-number listed on FDA's recall record

Z-1834-2024 — Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique.Class II·Ongoing·Macherey Nagel Gmbh & Co. Kg·20240404

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991927.

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