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FDA 510(k)

MPO ELISA TEST SYSTEM

K-Number: K961765 · 1996-08-19

ApplicantImmunoprobe, Inc.
Decision Date1996-08-19
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MPO ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Immunoprobe, Inc.. It received FDA 510(k) clearance on 1996-08-19 under 510(k) number K961765. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MPO ELISA TEST SYSTEM?

MPO ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1996-08-19. The listed applicant is Immunoprobe, Inc.. The 510(k) number is K961765.

When did MPO ELISA TEST SYSTEM receive FDA 510(k) clearance?

MPO ELISA TEST SYSTEM received FDA 510(k) clearance on 1996-08-19, under 510(k) number K961765.

Who is the listed applicant for MPO ELISA TEST SYSTEM?

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

What is the FDA product code for MPO ELISA TEST SYSTEM?

The FDA product code for MPO ELISA TEST SYSTEM is MOB.

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Other records listing Immunoprobe, 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.

K972406ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEMK971393MYCOPLASMA IGG ELISA TEST SYSTEMK961764PR-3 ELISA TEST SYSTEMK951549EBNA IGG EIA TEST SYSTEMK952521CARDIOLIPIN IGM EIA TEST SYSTEMK952522CARDIOLIPIN IGA EIA TEST SYSTEM

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Related Devices (Code: MOB)

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.

K261466Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMZeus ScientificK243776Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)Zeus ScientificK172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternEuroimmun Us, Inc.K172461AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinAesku.Diagnostics GmbH & Co. KGK173792EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayPhadia ABK161258NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitInova Diagnostics, 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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