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FDA 510(k)

#2007 XLD

K-Number: K820801 · 1982-04-08

ApplicantBiomedica, Inc.
Decision Date1982-04-08
Product CodeJSI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

#2007 XLD is the device name listed in this FDA 510(k) record. The listed applicant is Biomedica, Inc.. It received FDA 510(k) clearance on 1982-04-08 under 510(k) number K820801. 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 #2007 XLD?

#2007 XLD is a medical device that received FDA 510(k) clearance on 1982-04-08. The listed applicant is Biomedica, Inc.. The 510(k) number is K820801.

When did #2007 XLD receive FDA 510(k) clearance?

#2007 XLD received FDA 510(k) clearance on 1982-04-08, under 510(k) number K820801.

Who is the listed applicant for #2007 XLD?

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

What is the FDA product code for #2007 XLD?

The FDA product code for #2007 XLD is JSI.

Other records listing Biomedica, Inc. as applicant

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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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