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)

STERILABELS

K-Number: K864015 · 1986-12-12

ApplicantDiversatronics, Inc.
Decision Date1986-12-12
Product CodeLDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILABELS is the device name listed in this FDA 510(k) record. The listed applicant is Diversatronics, Inc.. It received FDA 510(k) clearance on 1986-12-12 under 510(k) number K864015. The device is classified under product code LDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILABELS?

STERILABELS is a medical device that received FDA 510(k) clearance on 1986-12-12. The listed applicant is Diversatronics, Inc.. The 510(k) number is K864015.

When did STERILABELS receive FDA 510(k) clearance?

STERILABELS received FDA 510(k) clearance on 1986-12-12, under 510(k) number K864015.

Who is the listed applicant for STERILABELS?

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

What is the FDA product code for STERILABELS?

The FDA product code for STERILABELS is LDQ.

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 Diversatronics, 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.

K896536PHARMATRONICS NEBULIZERK830143PNEUMATIC ANTERIOR CHAMBER MAINTAINER

Related Devices (Code: LDQ)

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.

K993797EC-7701 FLUID WARMING CABINETEnthermics Medical Systems, Inc.K992258HOT SHOT FLUID WARMER IV FLUIDSInfra-Med Technologies, Inc.K981032PIV SYSTEMMedical Solutions, Inc.K973747CONTROLLED TEMPERATURE CABINET SYSTEMSmithK955661ACU-HALTGlederer & Co., Inc.K955776ACU-LABGlederer & Co., 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.

↑