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FDA 510(k)

BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.

K-Number: K821347 · 1982-05-28

ApplicantBioclinical Corp.
Decision Date1982-05-28
Product CodeLCA
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. is the device name listed in this FDA 510(k) record. The listed applicant is Bioclinical Corp.. It received FDA 510(k) clearance on 1982-05-28 under 510(k) number K821347. The device is classified under product code LCA. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.?

BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. is a medical device that received FDA 510(k) clearance on 1982-05-28. The listed applicant is Bioclinical Corp.. The 510(k) number is K821347.

When did BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. receive FDA 510(k) clearance?

BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. received FDA 510(k) clearance on 1982-05-28, under 510(k) number K821347.

Who is the listed applicant for BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.?

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

What is the FDA product code for BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.?

The FDA product code for BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. is LCA.

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Related Devices (Code: LCA)

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.

K880291THEOPHYLLINE TEST KIT REF. #A874799Photec Diagnostics, Inc.K833789PHASE II THEOPHYLLINE RADIOIMMUNOASSAYMedical & Scientific Designs, Inc.K821862QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.Kallestad Laboratories, Inc.K792062THEOPHYLLINE RIASSAYRia Diagnostics

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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