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)

BACTON(TM), AUTO-APO A-1 REAGENT

K-Number: K921795 · 1992-06-23

ApplicantBacton Assay Systems, Inc.
Decision Date1992-06-23
Product CodeMSJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BACTON(TM), AUTO-APO A-1 REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Bacton Assay Systems, Inc.. It received FDA 510(k) clearance on 1992-06-23 under 510(k) number K921795. The device is classified under product code MSJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACTON(TM), AUTO-APO A-1 REAGENT?

BACTON(TM), AUTO-APO A-1 REAGENT is a medical device that received FDA 510(k) clearance on 1992-06-23. The listed applicant is Bacton Assay Systems, Inc.. The 510(k) number is K921795.

When did BACTON(TM), AUTO-APO A-1 REAGENT receive FDA 510(k) clearance?

BACTON(TM), AUTO-APO A-1 REAGENT received FDA 510(k) clearance on 1992-06-23, under 510(k) number K921795.

Who is the listed applicant for BACTON(TM), AUTO-APO A-1 REAGENT?

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

What is the FDA product code for BACTON(TM), AUTO-APO A-1 REAGENT?

The FDA product code for BACTON(TM), AUTO-APO A-1 REAGENT is MSJ.

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 Bacton Assay 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.

K921862BACTON(TM), AUTO-APO B REAGENT

Related Devices (Code: MSJ)

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.

K072977DIAZYME APOLIPOPROTEIN A-1 ASSAYGeneral AtomicsK073488DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXXDiazyme LaboratoriesK061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORSPointe Scientific, Inc.,K063608DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGHDade Behring, Inc.K9926628 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMBayer Corp.K970314SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTSBeckman Instruments, 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.

↑