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FDA 510(k)

IDS PORPHYRIN REAGENT

K-Number: K812859 · 1981-10-26

ApplicantInnovative Diagnostic Systems, Inc.
Decision Date1981-10-26
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IDS PORPHYRIN REAGENT 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 1981-10-26 under 510(k) number K812859. 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 PORPHYRIN REAGENT?

IDS PORPHYRIN REAGENT is a medical device that received FDA 510(k) clearance on 1981-10-26. The listed applicant is Innovative Diagnostic Systems, Inc.. The 510(k) number is K812859.

When did IDS PORPHYRIN REAGENT receive FDA 510(k) clearance?

IDS PORPHYRIN REAGENT received FDA 510(k) clearance on 1981-10-26, under 510(k) number K812859.

Who is the listed applicant for IDS PORPHYRIN REAGENT?

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 PORPHYRIN REAGENT?

The FDA product code for IDS PORPHYRIN REAGENT 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.

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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 SYSTEMK852871IDS RAPID SS/U SYSTEM

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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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