FDA 510(k)

ANTI-BLASTOMYCES CONTROL SERUM (YEAST)

K-Number: K760833 · 1976-11-01

Decision Date1976-11-01

Product CodeKFH

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ANTI-BLASTOMYCES CONTROL SERUM (YEAST) 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 K760833. The device is classified under product code KFH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-BLASTOMYCES CONTROL SERUM (YEAST)?

ANTI-BLASTOMYCES CONTROL SERUM (YEAST) 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 K760833.

When did ANTI-BLASTOMYCES CONTROL SERUM (YEAST) receive FDA 510(k) clearance?

ANTI-BLASTOMYCES CONTROL SERUM (YEAST) received FDA 510(k) clearance on 1976-11-01, under 510(k) number K760833.

Who is the listed applicant for ANTI-BLASTOMYCES CONTROL SERUM (YEAST)?

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 ANTI-BLASTOMYCES CONTROL SERUM (YEAST)?

The FDA product code for ANTI-BLASTOMYCES CONTROL SERUM (YEAST) is KFH.

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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Related Devices (Code: KFH)

K880029EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001Immuno-Mycologics, Inc.K792681BLASTOMYCES DERMATITIDIS POS/CONTROLMeridian Diagnostics, Inc.K792685BLASTOMYCES DERMATITIDIS, 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.