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FDA 510(k)

IDS RAPID SS/U SYSTEM

K-Number: K852871 · 1985-07-23

ApplicantInnovative Diagnostic Systems, Inc.
Decision Date1985-07-23
Product CodeJSS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IDS RAPID SS/U 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 1985-07-23 under 510(k) number K852871. The device is classified under product code JSS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDS RAPID SS/U SYSTEM?

IDS RAPID SS/U SYSTEM is a medical device that received FDA 510(k) clearance on 1985-07-23. The listed applicant is Innovative Diagnostic Systems, Inc.. The 510(k) number is K852871.

When did IDS RAPID SS/U SYSTEM receive FDA 510(k) clearance?

IDS RAPID SS/U SYSTEM received FDA 510(k) clearance on 1985-07-23, under 510(k) number K852871.

Who is the listed applicant for IDS RAPID SS/U 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 SS/U SYSTEM?

The FDA product code for IDS RAPID SS/U SYSTEM is JSS.

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.

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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 SYSTEMK852110IDS RAPID E PLUS SYSTEM

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Related Devices (Code: JSS)

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.

K123418GRAM-NEGATIVE QUICKFISH BCAdvandx, Inc.K101558GNR TRAFFIC LIGHT PNA FISHAdvandx, Inc.K092236E.COLI/P. AERUGINOSA PNA FISHAdvandx, Inc.K092393EK/P. AERUGINOSA PNA FISHAdvandx, Inc.K082068E. COLI PNA FISHAdvandx, Inc.K081433EK/P. AERUGINOSA PNA FISHAdvandx, 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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