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FDA 510(k)

BI PLATE-XLD/HEKTOEN #30012

K-Number: K821108 · 1982-05-13

ApplicantBiomedia, Inc.
Decision Date1982-05-13
Product CodeJSI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BI PLATE-XLD/HEKTOEN #30012 is the device name listed in this FDA 510(k) record. The listed applicant is Biomedia, Inc.. It received FDA 510(k) clearance on 1982-05-13 under 510(k) number K821108. 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 BI PLATE-XLD/HEKTOEN #30012?

BI PLATE-XLD/HEKTOEN #30012 is a medical device that received FDA 510(k) clearance on 1982-05-13. The listed applicant is Biomedia, Inc.. The 510(k) number is K821108.

When did BI PLATE-XLD/HEKTOEN #30012 receive FDA 510(k) clearance?

BI PLATE-XLD/HEKTOEN #30012 received FDA 510(k) clearance on 1982-05-13, under 510(k) number K821108.

Who is the listed applicant for BI PLATE-XLD/HEKTOEN #30012?

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

What is the FDA product code for BI PLATE-XLD/HEKTOEN #30012?

The FDA product code for BI PLATE-XLD/HEKTOEN #30012 is JSI.

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Other records listing Biomedia, 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.

K821300#2010 CAMPHYLOBACTER AGARK821301#50002 QUAD DIAGNOSTIC SYSTEMK821302#50003 QUAD DIAGNOSTIC SYSTEMK811473MUELLER HINTON AGAR W/5% SHEEP BLOODK811476THAYER MARTIN AGARK811478EMB AGAR, LEVINE

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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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