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FDA 510(k)

IDS RAPID STR SYSTEM

K-Number: K833654 · 1984-02-13

ApplicantInnovative Diagnostic Systems, Inc.
Decision Date1984-02-13
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IDS RAPID STR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1984-02-13 under 510(k) number K833654. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDS RAPID STR SYSTEM?

IDS RAPID STR SYSTEM is a medical device that received FDA 510(k) clearance on 1984-02-13. The listed applicant is Innovative Diagnostic Systems, Inc.. The 510(k) number is K833654.

When did IDS RAPID STR SYSTEM receive FDA 510(k) clearance?

IDS RAPID STR SYSTEM received FDA 510(k) clearance on 1984-02-13, under 510(k) number K833654.

Who is the listed applicant for IDS RAPID STR SYSTEM?

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

What is the FDA product code for IDS RAPID STR SYSTEM?

The FDA product code for IDS RAPID STR SYSTEM is JTO.

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 Innovative Diagnostic 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.

K962966IDS RAPID CB PLUS SYSTEMK943621RAPID YEAST PLUS SYSTEMK900517RAPID NF SYSTEMK882960IDS RAPID ANA SYSTEMK881501MODIFIED IDS RAPID NH SYSTEMK852871IDS RAPID SS/U SYSTEM

View all 11 devices →

Related Devices (Code: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic 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.

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