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FDA 510(k)

AUTOFLUOR IV SYSTEM

K-Number: K843181 · 1984-09-17

ApplicantTech America Diagnostics
Decision Date1984-09-17
Product CodeDBM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOFLUOR IV SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tech America Diagnostics. It received FDA 510(k) clearance on 1984-09-17 under 510(k) number K843181. 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 AUTOFLUOR IV SYSTEM?

AUTOFLUOR IV SYSTEM is a medical device that received FDA 510(k) clearance on 1984-09-17. The listed applicant is Tech America Diagnostics. The 510(k) number is K843181.

When did AUTOFLUOR IV SYSTEM receive FDA 510(k) clearance?

AUTOFLUOR IV SYSTEM received FDA 510(k) clearance on 1984-09-17, under 510(k) number K843181.

Who is the listed applicant for AUTOFLUOR IV SYSTEM?

The FDA 510(k) record lists Tech America Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOFLUOR IV SYSTEM?

The FDA product code for AUTOFLUOR IV SYSTEM is DBM.

Related Clinical Trials

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Other records listing Tech America Diagnostics 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.

K842991AUTOFLUOR V SYSTEMK841984AUTOFLOUR III SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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