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FDA 510(k)

CANDIDA DETECTION SYSTEM

K-Number: K823016 · 1982-12-28

ApplicantRamco Laboratories, Inc.
Decision Date1982-12-28
Product CodeLHK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CANDIDA DETECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ramco Laboratories, Inc.. It received FDA 510(k) clearance on 1982-12-28 under 510(k) number K823016. The device is classified under product code LHK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANDIDA DETECTION SYSTEM?

CANDIDA DETECTION SYSTEM is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is Ramco Laboratories, Inc.. The 510(k) number is K823016.

When did CANDIDA DETECTION SYSTEM receive FDA 510(k) clearance?

CANDIDA DETECTION SYSTEM received FDA 510(k) clearance on 1982-12-28, under 510(k) number K823016.

Who is the listed applicant for CANDIDA DETECTION SYSTEM?

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

What is the FDA product code for CANDIDA DETECTION SYSTEM?

The FDA product code for CANDIDA DETECTION SYSTEM is LHK.

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Other records listing Ramco Laboratories, 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.

K983107VFEK981208TFRK910481EPO-RIAK872941SPECTRO CK864701VWF IMMUNOBLOTK861159SPECTRO VWF

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Related Devices (Code: LHK)

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.

K893753DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TESTBd Becton Dickinson Vacutainer Systems PreanalyticK812741REAGENTS FOR SERODIAGNOSIS OF CANDIDOSISNolan Biological Laboratories, Inc.K812186CANDIDA IMMUNODIFFUSION SYSTEMAmerican Scientific Products

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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