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FDA 510(k)

VITAMIN B12 RADIOASSAY KIT CA-1534

K-Number: K832710 · 1983-10-04

ApplicantClinical Assays, Inc.
Decision Date1983-10-04
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITAMIN B12 RADIOASSAY KIT CA-1534 is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Assays, Inc.. It received FDA 510(k) clearance on 1983-10-04 under 510(k) number K832710. 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 VITAMIN B12 RADIOASSAY KIT CA-1534?

VITAMIN B12 RADIOASSAY KIT CA-1534 is a medical device that received FDA 510(k) clearance on 1983-10-04. The listed applicant is Clinical Assays, Inc.. The 510(k) number is K832710.

When did VITAMIN B12 RADIOASSAY KIT CA-1534 receive FDA 510(k) clearance?

VITAMIN B12 RADIOASSAY KIT CA-1534 received FDA 510(k) clearance on 1983-10-04, under 510(k) number K832710.

Who is the listed applicant for VITAMIN B12 RADIOASSAY KIT CA-1534?

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

What is the FDA product code for VITAMIN B12 RADIOASSAY KIT CA-1534?

The FDA product code for VITAMIN B12 RADIOASSAY KIT CA-1534 is CDD.

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Other records listing Clinical Assays, 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.

K832712FOLATE RADIOASSAY KIT CA-1562-125K832711VITAMIN B12 FOLATE CA-1515-125K823476GAMMADAB LH RADIO-KIT #CA-1508K823313IN VITRO GAMMACOAT B-HCG RADIO. TESTK821611GAMMADAB [125] FSH RADIOIMMUNAY KITK821092GAMMADAB[125]EGE RADIOIMMUNOASSAY IT

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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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