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FDA 510(k)

MITOCHONDRIA EIA TEST KIT

K-Number: K940251 · 1994-05-03

ApplicantDavid A. Fuccillo, Ph.D.
Decision Date1994-05-03
Product CodeDBM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MITOCHONDRIA EIA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is David A. Fuccillo, Ph.D.. It received FDA 510(k) clearance on 1994-05-03 under 510(k) number K940251. The device is classified under product code DBM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MITOCHONDRIA EIA TEST KIT?

MITOCHONDRIA EIA TEST KIT is a medical device that received FDA 510(k) clearance on 1994-05-03. The listed applicant is David A. Fuccillo, Ph.D.. The 510(k) number is K940251.

When did MITOCHONDRIA EIA TEST KIT receive FDA 510(k) clearance?

MITOCHONDRIA EIA TEST KIT received FDA 510(k) clearance on 1994-05-03, under 510(k) number K940251.

Who is the listed applicant for MITOCHONDRIA EIA TEST KIT?

The FDA 510(k) record lists David A. Fuccillo, Ph.D. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MITOCHONDRIA EIA TEST KIT?

The FDA product code for MITOCHONDRIA EIA TEST KIT is DBM.

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Other records listing David A. Fuccillo, Ph.D. 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.

K935413ENA EIA TEST KITK935417JO-1 EIA TEST KITK935419LA EIA TEST KITK935418SCL-70 EIA TEST KITK935414SM EIA TEST KITK935415RNP EIA TEST KIT

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Related Devices (Code: DBM)

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.

K181556EliA M2 ImmunoassayPhadia ABK163525QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) ControlsInova Diagnostics, Inc.K163133ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.K092736EUROIMMUN ANTI-M2-3E ELISA (IGG)Euroimmun Us, Inc.K052262QUANTA LITE M2 EP (MIT3) ELISAInova Diagnostics, Inc.K031308RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760Rhigene, 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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