MLA ELECTRA 700— 510(k) K812124

Name: FDA 510(k) clearance K812124
Creator: U.S. Food and Drug Administration
Published: 1981-10-02

Substantially Equivalent

Medical Laboratory Automation Systems, Inc.

FDA 510(k) clearance K812124 for MLA ELECTRA 700, Substantially Equivalent on 1981-10-02. Applicant: Medical Laboratory Automation Systems, Inc.. Device class: 2.

Clearance details

Applicant: Medical Laboratory Automation Systems, Inc.
Product code: Code JPA
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1981-07-27
Decision date: 1981-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JPA

view all

K253658 — STA Satellite Max®2026-04-27
K250965 — Automated Blood Coagulation Analyzer CN-Series (CN-6000)2025-06-02
K251024 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge2025-04-30
K243858 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge2025-01-15
K232018 — Citrated: K, KH, RTH, FFH2024-03-29

More clearances from Medical Laboratory Automation Systems, Inc.

view all

K962664 — ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER1996-09-10
K944227 — ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER1995-02-03
K931206 — ELECTRA 1600C AUTOMATIC COAGULATION TIMER1993-08-23
K923220 — THROMBIN CLOT TIME TEST PROCEDURE1992-09-29
K903638 — GASTRO-INTESTINAL ACCU-CULSHURE TM1991-01-18

Adverse events under product code JPA

product code JPA

Death: 6
Total: 6

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.