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FDA 510(k)

SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC

K-Number: K850723 · 1985-03-22

ApplicantRapid City Regional Hospital, Inc.
Decision Date1985-03-22
Product CodeJSI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC is the device name listed in this FDA 510(k) record. The listed applicant is Rapid City Regional Hospital, Inc.. It received FDA 510(k) clearance on 1985-03-22 under 510(k) number K850723. The device is classified under product code JSI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC?

SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC is a medical device that received FDA 510(k) clearance on 1985-03-22. The listed applicant is Rapid City Regional Hospital, Inc.. The 510(k) number is K850723.

When did SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC receive FDA 510(k) clearance?

SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC received FDA 510(k) clearance on 1985-03-22, under 510(k) number K850723.

Who is the listed applicant for SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC?

The FDA 510(k) record lists Rapid City Regional Hospital, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC?

The FDA product code for SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC is JSI.

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Other records listing Rapid City Regional Hospital, 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.

K850724CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIALK850719DNASE TEST MEDIA, CHRISTENSEN'S UREA AGARK850716SELENITE F BROTHK850720EOSIN METHYLENE BLUE AGAR, SS AGAR, XLD AGAR 6.5%K850722MARTIN LEWIS AGARK850717AMIES TRANSPORT MEDIA

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Related Devices (Code: JSI)

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.

K070691BBL CHROMAGAR 0157Becton, Dickinson & COK974428DIPSTREAKNovamed , Ltd.K891593LISTERIA SELECTIVE ENRICHMENT MEDIUMOxoid U.S.A., Inc.K890199DENTOCULT SM-STRIP MUTANSOrion Corp.K882182SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326Lakewood Biochemical Co., Inc.K881575SELECTIVE STREPTOCOCCUS AGARAcumedia Manufacturers, 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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