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FDA 510(k)

REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS

K-Number: K812741 · 1981-10-23

ApplicantNolan Biological Laboratories, Inc.
Decision Date1981-10-23
Product CodeLHK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS is the device name listed in this FDA 510(k) record. The listed applicant is Nolan Biological Laboratories, Inc.. It received FDA 510(k) clearance on 1981-10-23 under 510(k) number K812741. 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 REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS?

REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS is a medical device that received FDA 510(k) clearance on 1981-10-23. The listed applicant is Nolan Biological Laboratories, Inc.. The 510(k) number is K812741.

When did REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS receive FDA 510(k) clearance?

REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS received FDA 510(k) clearance on 1981-10-23, under 510(k) number K812741.

Who is the listed applicant for REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS?

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

What is the FDA product code for REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS?

The FDA product code for REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS is LHK.

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Other records listing Nolan Biological 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.

K812740REAGENTS FOR SERODIAGNOSIS OF ASPERGILLK802129IMMUNODIFFUSION REAGENTS/SEROLOGICALK802130IMMUNO. IDENTIFICATION OF H. CAPSULATUMK802128IMMUNODIFFUSSION REAGENTS/SEROLOGICAL

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 PreanalyticK823016CANDIDA DETECTION SYSTEMRamco Laboratories, Inc.K812186CANDIDA IMMUNODIFFUSION SYSTEMAmerican Scientific Products

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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