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)

RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE

K-Number: K072827 · 2007-11-26

ApplicantRemel, Inc.
Decision Date2007-11-26
Product CodeMJE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE is the device name listed in this FDA 510(k) record. The listed applicant is Remel, Inc.. It received FDA 510(k) clearance on 2007-11-26 under 510(k) number K072827. The device is classified under product code MJE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE?

RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE is a medical device that received FDA 510(k) clearance on 2007-11-26. The listed applicant is Remel, Inc.. The 510(k) number is K072827.

When did RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE receive FDA 510(k) clearance?

RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE received FDA 510(k) clearance on 2007-11-26, under 510(k) number K072827.

Who is the listed applicant for RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE?

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

What is the FDA product code for RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE?

The FDA product code for RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE is MJE.

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, 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.

K162620Remel Spectra ESBLK131804REMEL XPECT FLU A&BK092407REMEL SPECTRA MRSAK041951XPECT CLOSTRIDIUM DIFFICILE TOXIN A/BK033479PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAYK031942XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020

View all 17 devices →

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.

↑