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FDA 510(k)

QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.

K-Number: K821862 · 1982-07-06

ApplicantKallestad Laboratories, Inc.
Decision Date1982-07-06
Product CodeLCA
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1982-07-06 under 510(k) number K821862. 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 QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.?

QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. is a medical device that received FDA 510(k) clearance on 1982-07-06. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K821862.

When did QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. receive FDA 510(k) clearance?

QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. received FDA 510(k) clearance on 1982-07-06, under 510(k) number K821862.

Who is the listed applicant for QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.?

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

What is the FDA product code for QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.?

The FDA product code for QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. is LCA.

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Other records listing Kallestad Laboratories, Inc. as applicant

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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.K821347BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.Bioclinical Corp.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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