Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MLA ELECTRA 700

K-Number: K812124 · 1981-10-02

ApplicantMedical Laboratory Automation Systems, Inc.
Decision Date1981-10-02
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MLA ELECTRA 700 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Laboratory Automation Systems, Inc.. It received FDA 510(k) clearance on 1981-10-02 under 510(k) number K812124. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MLA ELECTRA 700?

MLA ELECTRA 700 is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is Medical Laboratory Automation Systems, Inc.. The 510(k) number is K812124.

When did MLA ELECTRA 700 receive FDA 510(k) clearance?

MLA ELECTRA 700 received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812124.

Who is the listed applicant for MLA ELECTRA 700?

The FDA 510(k) record lists Medical Laboratory Automation Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MLA ELECTRA 700?

The FDA product code for MLA ELECTRA 700 is JPA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medical Laboratory Automation Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K962664ELECTRA 1800C AUTOMATIC COAGULATION ANALYZERK944227ELECTRA 1400C AUTOMATIC COAGULATION ANALYZERK931206ELECTRA 1600C AUTOMATIC COAGULATION TIMERK923220THROMBIN CLOT TIME TEST PROCEDUREK903638GASTRO-INTESTINAL ACCU-CULSHURE TMK903405CHLAMYDIA ACCU-CULSHURE TM

View all 17 devices →

Related Devices (Code: JPA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemoneticsK243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics CorporationK232018Citrated: K, KH, RTH, FFHHaemonetics CorporationK233790ACL TOP 970 CLInstrumentation Laboratory

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑