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FDA 510(k)

BLASTOMYCES YEAST ANTIGEN

K-Number: K760828 · 1976-11-01

ApplicantI M, Inc.
Decision Date1976-11-01
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLASTOMYCES YEAST 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 K760828. The device is classified under product code JJJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLASTOMYCES YEAST ANTIGEN?

BLASTOMYCES YEAST 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 K760828.

When did BLASTOMYCES YEAST ANTIGEN receive FDA 510(k) clearance?

BLASTOMYCES YEAST ANTIGEN received FDA 510(k) clearance on 1976-11-01, under 510(k) number K760828.

Who is the listed applicant for BLASTOMYCES YEAST 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 BLASTOMYCES YEAST ANTIGEN?

The FDA product code for BLASTOMYCES YEAST ANTIGEN is JJJ.

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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: JJJ)

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.

K962762SEQUENTIAL SAMPLE MULTI-PHOTON DETECTORBiotraces, Inc.K946387CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTERCapintec, Inc.K920559ABBOTT VERTEX ANALYZERAbbott LaboratoriesK900087GENESYS 6000 GAMMA COUNTERLaboratory Technologies, Inc.K896202MATRIX(TM)-96Canberra Industries, Inc.K894902SOURCEREROakfield Instruments, Ltd.

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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