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FDA 510(k)

BISMUTH SULFITE AGAR

K-Number: K800157 · 1980-02-13

ApplicantIsle Media and Sterile Products, Inc.
Decision Date1980-02-13
Product CodeJSI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BISMUTH SULFITE AGAR is the device name listed in this FDA 510(k) record. The listed applicant is Isle Media and Sterile Products, Inc.. It received FDA 510(k) clearance on 1980-02-13 under 510(k) number K800157. 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 BISMUTH SULFITE AGAR?

BISMUTH SULFITE AGAR is a medical device that received FDA 510(k) clearance on 1980-02-13. The listed applicant is Isle Media and Sterile Products, Inc.. The 510(k) number is K800157.

When did BISMUTH SULFITE AGAR receive FDA 510(k) clearance?

BISMUTH SULFITE AGAR received FDA 510(k) clearance on 1980-02-13, under 510(k) number K800157.

Who is the listed applicant for BISMUTH SULFITE AGAR?

The FDA 510(k) record lists Isle Media and Sterile Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BISMUTH SULFITE AGAR?

The FDA product code for BISMUTH SULFITE AGAR is JSI.

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Other records listing Isle Media and Sterile Products, 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.

K831671MODIFIED SOYBEAN CASEIN DIGEST BROTHK821218CAMPY-S AGARK820863MEDIA FOR IN-VITRO DIAGNOSTIC USEK812796ANAEROBIC CNA BLOOD AGARK812795ANAEROBIC BLOOD AGARK812798MOTILITY GI MEDIUM

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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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