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FDA 510(k)

MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY

K-Number: K854945 · 1986-02-11

ApplicantCiba Corning Diagnostics Corp.
Decision Date1986-02-11
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Ciba Corning Diagnostics Corp.. It received FDA 510(k) clearance on 1986-02-11 under 510(k) number K854945. 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 MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY?

MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1986-02-11. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K854945.

When did MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY receive FDA 510(k) clearance?

MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY received FDA 510(k) clearance on 1986-02-11, under 510(k) number K854945.

Who is the listed applicant for MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY?

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

What is the FDA product code for MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY?

The FDA product code for MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY is CDD.

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Other records listing Ciba Corning Diagnostics 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.

K962559ACS CORTISOL IMMUNOASSAYK963251CIBA CORNING ACS;180 DPD ASSAYK961807CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4K961657CIBA CORNING 400 SYSTEMK962021CIBA CORNING 348 SYSTEMK962126ACS CKMB II IMMUNOASSAY

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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

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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