HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)— 510(k) K991362

Name: FDA 510(k) clearance K991362
Creator: U.S. Food and Drug Administration
Published: 1999-06-21

Substantially Equivalent

Morax

FDA 510(k) clearance K991362 for HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO), Substantially Equivalent on 1999-06-21. Applicant: Morax. Device class: 2.

Clearance details

Applicant: Morax
Product code: Code JBD
Device class: Class 2
Regulation: 21 CFR 864.7440
Advisory panel: Hematology
Date received: 1999-04-14
Decision date: 1999-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelsea, MI, US

Download summary PDF View on FDA.gov ↗

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K990250 — HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 01999-06-18
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