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)

LIQUI-SERA SERUM ALCOHOL CONTROLS

K-Number: K881430 · 1988-07-08

ApplicantBiodiagnostic Intl
Decision Date1988-07-08
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIQUI-SERA SERUM ALCOHOL CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Biodiagnostic Intl. It received FDA 510(k) clearance on 1988-07-08 under 510(k) number K881430. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIQUI-SERA SERUM ALCOHOL CONTROLS?

LIQUI-SERA SERUM ALCOHOL CONTROLS is a medical device that received FDA 510(k) clearance on 1988-07-08. The listed applicant is Biodiagnostic Intl. The 510(k) number is K881430.

When did LIQUI-SERA SERUM ALCOHOL CONTROLS receive FDA 510(k) clearance?

LIQUI-SERA SERUM ALCOHOL CONTROLS received FDA 510(k) clearance on 1988-07-08, under 510(k) number K881430.

Who is the listed applicant for LIQUI-SERA SERUM ALCOHOL CONTROLS?

The FDA 510(k) record lists Biodiagnostic Intl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIQUI-SERA SERUM ALCOHOL CONTROLS?

The FDA product code for LIQUI-SERA SERUM ALCOHOL CONTROLS is JJX.

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 Biodiagnostic Intl 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.

K031296LIQUI-HEME GLYCO A1C ASSAYK874459LIQUI-SERA SPINAL FLUID CONTROLK863849LIQUI-SERA COMBO LIGAND/TDM CONTROLSK853906LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE)K853887LIQUI-SERA CHEM. MULTIPLE CALIBRATORSK842668LIQUI-HEME HEMOGLOBIN CALIBRATORS

View all 11 devices →

Related Devices (Code: JJX)

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.

K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.

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.

↑