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)

BACTIDROP KOH (10%)

K-Number: K920970 · 1992-06-09

ApplicantRemel Co.
Decision Date1992-06-09
Product CodeJTS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BACTIDROP KOH (10%) is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1992-06-09 under 510(k) number K920970. The device is classified under product code JTS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACTIDROP KOH (10%)?

BACTIDROP KOH (10%) is a medical device that received FDA 510(k) clearance on 1992-06-09. The listed applicant is Remel Co.. The 510(k) number is K920970.

When did BACTIDROP KOH (10%) receive FDA 510(k) clearance?

BACTIDROP KOH (10%) received FDA 510(k) clearance on 1992-06-09, under 510(k) number K920970.

Who is the listed applicant for BACTIDROP KOH (10%)?

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 BACTIDROP KOH (10%)?

The FDA product code for BACTIDROP KOH (10%) is JTS.

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. IIIK965150A.C.T. IVK965152A.C.T. IIK965149A.C.T. IK960090CALCOFLUOR WHITE STAIN KIT

View all 137 devices →

Related Devices (Code: JTS)

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.

K960090CALCOFLUOR WHITE STAIN KITRemel Co.K960095BACTIDROP CALCOFLUOR WHITERemel Co.K920975BACTIDROP CALCOFLUOR WHITERemel Co.K920976BACTIDROP INDIA INKRemel Co.K893530IRISTAIN FORMULA 2, PARTS 1 AND 2Intl. Remote Imaging SystemsK890861ATS DOBELL & O'CONNOR'S IODINEAlpha-Tec Systems, 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.

↑