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FDA 510(k)

ASPERGILLUS MYCELIAL ANTIGEN

K-Number: K760830 · 1976-11-01

ApplicantI M, Inc.
Decision Date1976-11-01
Product CodeJWT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ASPERGILLUS MYCELIAL ANTIGEN is the device name listed in this FDA 510(k) record. The listed applicant is I M, Inc.. It received FDA 510(k) clearance on 1976-11-01 under 510(k) number K760830. 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 MYCELIAL ANTIGEN?

ASPERGILLUS MYCELIAL ANTIGEN is a medical device that received FDA 510(k) clearance on 1976-11-01. The listed applicant is I M, Inc.. The 510(k) number is K760830.

When did ASPERGILLUS MYCELIAL ANTIGEN receive FDA 510(k) clearance?

ASPERGILLUS MYCELIAL ANTIGEN received FDA 510(k) clearance on 1976-11-01, under 510(k) number K760830.

Who is the listed applicant for ASPERGILLUS MYCELIAL ANTIGEN?

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

What is the FDA product code for ASPERGILLUS MYCELIAL ANTIGEN?

The FDA product code for ASPERGILLUS MYCELIAL ANTIGEN 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.

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Other records listing I M, 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.

K914600NEUROLOGICAL SPONGEK892389BIOPSY KITK881363SYRINGE PREFILLED WITH WATERK880753UMBILICAL CORD CLAMPK872741NUTRIPUMPK871495BANDAGES CATALOG NUMBER: 101 TO 220

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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.K790672ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVUDiagnostica, 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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