FDA 510(k)

FUNGAL IMMUNODIFFUSION KIT

K-Number: K760825 · 1976-11-16

Decision Date1976-11-16

Product Code

DecisionSubstantially Equivalent

Device Summary

FUNGAL IMMUNODIFFUSION KIT 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 1976-11-16 under 510(k) number K760825. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUNGAL IMMUNODIFFUSION KIT?

FUNGAL IMMUNODIFFUSION KIT is a medical device that received FDA 510(k) clearance on 1976-11-16. The listed applicant is I M, Inc.. The 510(k) number is K760825.

When did FUNGAL IMMUNODIFFUSION KIT receive FDA 510(k) clearance?

FUNGAL IMMUNODIFFUSION KIT received FDA 510(k) clearance on 1976-11-16, under 510(k) number K760825.

Who is the listed applicant for FUNGAL IMMUNODIFFUSION KIT?

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

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

K914600NEUROLOGICAL SPONGE K892389BIOPSY KIT K881363SYRINGE PREFILLED WITH WATER K880753UMBILICAL CORD CLAMP K872741NUTRIPUMP K871495BANDAGES CATALOG NUMBER: 101 TO 220

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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.