MSI-HB HEMOGLOBIN CONTROL— 510(k) K853776

Name: FDA 510(k) clearance K853776
Creator: U.S. Food and Drug Administration
Published: 1985-09-19

Substantially Equivalent

Medical Specialties, Inc.

FDA 510(k) clearance K853776 for MSI-HB HEMOGLOBIN CONTROL, Substantially Equivalent on 1985-09-19. Applicant: Medical Specialties, Inc.. Device class: 2.

Clearance details

Applicant: Medical Specialties, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1985-09-10
Decision date: 1985-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Plainfield, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K853776

K-number listed on FDA's recall record

Z-1249-2021 — RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement.Class II·Terminated·Medline Industries Inc·20210125

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K853776.

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