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FDA 510(k)

MESACUP MODELS BP180 AND BP230 ELISA KITS

K-Number: K071961 · 2008-08-25

ApplicantMbl International Corporation
Decision Date2008-08-25
Product CodeOEG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MESACUP MODELS BP180 AND BP230 ELISA KITS is the device name listed in this FDA 510(k) record. The listed applicant is Mbl International Corporation. It received FDA 510(k) clearance on 2008-08-25 under 510(k) number K071961. The device is classified under product code OEG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MESACUP MODELS BP180 AND BP230 ELISA KITS?

MESACUP MODELS BP180 AND BP230 ELISA KITS is a medical device that received FDA 510(k) clearance on 2008-08-25. The listed applicant is Mbl International Corporation. The 510(k) number is K071961.

When did MESACUP MODELS BP180 AND BP230 ELISA KITS receive FDA 510(k) clearance?

MESACUP MODELS BP180 AND BP230 ELISA KITS received FDA 510(k) clearance on 2008-08-25, under 510(k) number K071961.

Who is the listed applicant for MESACUP MODELS BP180 AND BP230 ELISA KITS?

The FDA 510(k) record lists Mbl International Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MESACUP MODELS BP180 AND BP230 ELISA KITS?

The FDA product code for MESACUP MODELS BP180 AND BP230 ELISA KITS is OEG.

Related Clinical Trials

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Other records listing Mbl International Corporation 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.

K060431ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805

Related Devices (Code: OEG)

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.

K193115EUROIMMUN Anti-BP230-CF ELISA (IgG)Euroimmun Us, Inc.K083615EUROIMMUN ANTI BP 180-4X ELISA (IGG)Euroimmun Us, 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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