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)

SERACON-HDL

K-Number: K782171 · 1979-02-08

ApplicantBhp Diagnostix, Inc.
Decision Date1979-02-08
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERACON-HDL is the device name listed in this FDA 510(k) record. The listed applicant is Bhp Diagnostix, Inc.. It received FDA 510(k) clearance on 1979-02-08 under 510(k) number K782171. 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 SERACON-HDL?

SERACON-HDL is a medical device that received FDA 510(k) clearance on 1979-02-08. The listed applicant is Bhp Diagnostix, Inc.. The 510(k) number is K782171.

When did SERACON-HDL receive FDA 510(k) clearance?

SERACON-HDL received FDA 510(k) clearance on 1979-02-08, under 510(k) number K782171.

Who is the listed applicant for SERACON-HDL?

The FDA 510(k) record lists Bhp Diagnostix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERACON-HDL?

The FDA product code for SERACON-HDL 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 Bhp Diagnostix, 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.

K904503SERACON CR REFERENCEK863648SERACON CT REFERENCEK862594SERACON(TM) CAL (PRODUCT NO. DO35)K844928QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCEK844927QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETSK844027SERACON TM SR III

View all 25 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.

↑