AUTOMATIC BIOCHEMICAL ANALYZER— 510(k) K810063

Name: FDA 510(k) clearance K810063
Creator: U.S. Food and Drug Administration
Published: 1981-01-26

Substantially Equivalent

Acculab

FDA 510(k) clearance K810063 for AUTOMATIC BIOCHEMICAL ANALYZER, Substantially Equivalent on 1981-01-26. Applicant: Acculab. Device class: 1.

Clearance details

Applicant: Acculab
Product code: Code JQP
Device class: Class 1
Regulation: 21 CFR 862.2100
Advisory panel: Clinical Chemistry
Date received: 1981-01-13
Decision date: 1981-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JQP

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K113007 — BIONIME DIABETES MANAGEMENT SYSTEM VI.02012-02-27
K983468 — FASTTAKE ADAPTER, MODEL # P/N 020-072-011998-12-17
K964460 — THE ROBOLITE1997-01-24
K953652 — PRENVAL I1995-09-15
K934111 — MR7000 WITH TIME MANAGER SOFTWARE (TMS)1994-11-02

Adverse events under product code JQP

product code JQP

Death: 3
Malfunction: 690
Total: 693

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.