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)

BHI AGAR WITH VANCOMYCIN

K-Number: K941444 · 1994-09-19

ApplicantRemel Co.
Decision Date1994-09-19
Product CodeJSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BHI AGAR WITH VANCOMYCIN is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1994-09-19 under 510(k) number K941444. The device is classified under product code JSO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BHI AGAR WITH VANCOMYCIN?

BHI AGAR WITH VANCOMYCIN is a medical device that received FDA 510(k) clearance on 1994-09-19. The listed applicant is Remel Co.. The 510(k) number is K941444.

When did BHI AGAR WITH VANCOMYCIN receive FDA 510(k) clearance?

BHI AGAR WITH VANCOMYCIN received FDA 510(k) clearance on 1994-09-19, under 510(k) number K941444.

Who is the listed applicant for BHI AGAR WITH VANCOMYCIN?

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

What is the FDA product code for BHI AGAR WITH VANCOMYCIN?

The FDA product code for BHI AGAR WITH VANCOMYCIN is JSO.

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 Remel Co. 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.

K013711BACTI-SWAB DRYK965151A.C.T. IIIK965152A.C.T. IIK965150A.C.T. IVK965149A.C.T. IK960090CALCOFLUOR WHITE STAIN KIT

View all 137 devices →

Related Devices (Code: JSO)

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.

K190553HardyCHROM CREHardy DiagnosticsK181092CHROMID CARBA agar (CARB)Biomerieux S.A.K171061MRSASelect IIBio-RadK162620Remel Spectra ESBLRemel, Inc.K160512HardyCHROM ESBLHardy DiagnosticsK162076chromID MRSAbioMerieux, 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.

↑