Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CANDIDA IMMUNODIFFUSION SYSTEM

K-Number: K812186 · 1981-08-25

ApplicantAmerican Scientific Products
Decision Date1981-08-25
Product CodeLHK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CANDIDA IMMUNODIFFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Scientific Products. It received FDA 510(k) clearance on 1981-08-25 under 510(k) number K812186. 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 IMMUNODIFFUSION SYSTEM?

CANDIDA IMMUNODIFFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1981-08-25. The listed applicant is American Scientific Products. The 510(k) number is K812186.

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

CANDIDA IMMUNODIFFUSION SYSTEM received FDA 510(k) clearance on 1981-08-25, under 510(k) number K812186.

Who is the listed applicant for CANDIDA IMMUNODIFFUSION SYSTEM?

The FDA 510(k) record lists American Scientific Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CANDIDA IMMUNODIFFUSION SYSTEM?

The FDA product code for CANDIDA IMMUNODIFFUSION SYSTEM is LHK.

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 American Scientific Products 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.

K864824INFECTIOUS TISSUE KITK844042BLOOD DILUTION VIALK831634GLUCOSE REAGENT B6360-11K831625UREA NITROGEN-BUN-REAGENTS B6360-12K831626UREA NITROGEN-BUN-REAGENTS B6370-11AK831628CREATININE REAGENTS B6370-13

View all 28 devices →

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.K812741REAGENTS FOR SERODIAGNOSIS OF CANDIDOSISNolan Biological Laboratories, 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.

↑