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FDA 510(k)

CANDIDA IMMUNODIFFUSION KIT

K-Number: K770527 · 1978-03-17

ApplicantI M, Inc.
Decision Date1978-03-17
Product CodeGMI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CANDIDA 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 1978-03-17 under 510(k) number K770527. The device is classified under product code GMI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANDIDA IMMUNODIFFUSION KIT?

CANDIDA IMMUNODIFFUSION KIT is a medical device that received FDA 510(k) clearance on 1978-03-17. The listed applicant is I M, Inc.. The 510(k) number is K770527.

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

CANDIDA IMMUNODIFFUSION KIT received FDA 510(k) clearance on 1978-03-17, under 510(k) number K770527.

Who is the listed applicant for CANDIDA IMMUNODIFFUSION KIT?

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 CANDIDA IMMUNODIFFUSION KIT?

The FDA product code for CANDIDA IMMUNODIFFUSION KIT is GMI.

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

View all 41 devices →

Related Devices (Code: GMI)

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.

K894617OLYMPUS PK-TP SYSTEM REACTIVE CONTROLSchiff & Co.K812190COCCIDIOIDES IMMUNODIFFUSION SYSTEMAmerican Scientific ProductsK812185FUNGAL IMMUNODIFFUSION SYSTEMAmerican Scientific ProductsK802129IMMUNODIFFUSION REAGENTS/SEROLOGICALNolan Biological Laboratories, Inc.K792716CANDIDA ALBICANS, ANTIGENMeridian Diagnostics, Inc.K792713CANDIDA ALBICANS, ANTISERUMMeridian Diagnostics, 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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