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)

ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU

K-Number: K790672 · 1979-05-31

ApplicantDiagnostica, Inc.
Decision Date1979-05-31
Product CodeJWT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica, Inc.. It received FDA 510(k) clearance on 1979-05-31 under 510(k) number K790672. The device is classified under product code JWT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU?

ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU is a medical device that received FDA 510(k) clearance on 1979-05-31. The listed applicant is Diagnostica, Inc.. The 510(k) number is K790672.

When did ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU receive FDA 510(k) clearance?

ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU received FDA 510(k) clearance on 1979-05-31, under 510(k) number K790672.

Who is the listed applicant for ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU?

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

What is the FDA product code for ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU?

The FDA product code for ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU is JWT.

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 Diagnostica, 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.

K002756EASE-A-CULTK823348H. INFLUENZA B ANTISERA FOR CIEK812434DIAGNOSTIC KITS & KIT COMPONENTSK800398PARACONTROL ABNORMAL IMMUNOGLOBULIN CONTK791283ANTI-HUMAN LAMBDA SERUMK791281ANTI-HUMAN IGG SERUM

View all 12 devices →

Related Devices (Code: JWT)

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 ASPERGILLNolan Biological Laboratories, Inc.K792700ASPERGILLUS SP, COMPLEMENT FIXATIONMeridian Diagnostics, Inc.K791387ASPERGILLUS MYCELIAL ANTIGEN #CF10024XImmuno-Mycologics, Inc.K760830ASPERGILLUS MYCELIAL ANTIGENI M, 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.

↑