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FDA 510(k)

ATS PARA-SET IODINE ALCOHOL SOLUTION

K-Number: K883049 · 1988-08-17

ApplicantAlpha-Tec Systems, Inc.
Decision Date1988-08-17
Product CodeJTS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ATS PARA-SET IODINE ALCOHOL SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Alpha-Tec Systems, Inc.. It received FDA 510(k) clearance on 1988-08-17 under 510(k) number K883049. 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 ATS PARA-SET IODINE ALCOHOL SOLUTION?

ATS PARA-SET IODINE ALCOHOL SOLUTION is a medical device that received FDA 510(k) clearance on 1988-08-17. The listed applicant is Alpha-Tec Systems, Inc.. The 510(k) number is K883049.

When did ATS PARA-SET IODINE ALCOHOL SOLUTION receive FDA 510(k) clearance?

ATS PARA-SET IODINE ALCOHOL SOLUTION received FDA 510(k) clearance on 1988-08-17, under 510(k) number K883049.

Who is the listed applicant for ATS PARA-SET IODINE ALCOHOL SOLUTION?

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

What is the FDA product code for ATS PARA-SET IODINE ALCOHOL SOLUTION?

The FDA product code for ATS PARA-SET IODINE ALCOHOL SOLUTION 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 Alpha-Tec 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.

K053257PARA-PRO FC50K890861ATS DOBELL & O'CONNOR'S IODINEK890020ATS LUGOL'S IODINE SOLUTIONK890148ATS TB RAPID STAIN SET PRODUCT #034-45K890022ATS MAYER'S ALBUMINK883048ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION

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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.K920970BACTIDROP KOH (10%)Remel Co.K920976BACTIDROP INDIA INKRemel Co.K920975BACTIDROP CALCOFLUOR WHITERemel Co.K893530IRISTAIN FORMULA 2, PARTS 1 AND 2Intl. Remote Imaging Systems

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.

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