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FDA 510(k)

DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA

K-Number: K851377 · 1985-08-21

ApplicantDiagnon Corp.
Decision Date1985-08-21
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA is the device name listed in this FDA 510(k) record. The listed applicant is Diagnon Corp.. It received FDA 510(k) clearance on 1985-08-21 under 510(k) number K851377. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA?

DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA is a medical device that received FDA 510(k) clearance on 1985-08-21. The listed applicant is Diagnon Corp.. The 510(k) number is K851377.

When did DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA receive FDA 510(k) clearance?

DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA received FDA 510(k) clearance on 1985-08-21, under 510(k) number K851377.

Who is the listed applicant for DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA?

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

What is the FDA product code for DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA?

The FDA product code for DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA is CDD.

Related Clinical Trials

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Other records listing Diagnon Corp. 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.

K860967VIRTRAN VIRAL TRANSPORTER (MODIFIED)K851635DIAGNON HERPES IMMUNOPEROXIDASE TYPING TESTK851378VIRTRAN VIRAL TRANPORTERK841302DIAGNON FOLATE 125I RIA KITK832717DIAGNON B12 57CO RIA KIT

Related Devices (Code: CDD)

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.

K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.K223289Access Vitamin B12Beckman Coulter, Inc.K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12Beckman Coulter Biomedical GmbHK192064LIAISON Vitamin B12DiaSorin, Inc.K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd.K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme Laboratories

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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