FDA 510(k)

PHASE II THEOPHYLLINE RADIOIMMUNOASSAY

K-Number: K833789 · 1984-01-24

ApplicantMedical & Scientific Designs, Inc.

Decision Date1984-01-24

Product CodeLCA

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

PHASE II THEOPHYLLINE RADIOIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Medical & Scientific Designs, Inc.. It received FDA 510(k) clearance on 1984-01-24 under 510(k) number K833789. 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 PHASE II THEOPHYLLINE RADIOIMMUNOASSAY?

PHASE II THEOPHYLLINE RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1984-01-24. The listed applicant is Medical & Scientific Designs, Inc.. The 510(k) number is K833789.

When did PHASE II THEOPHYLLINE RADIOIMMUNOASSAY receive FDA 510(k) clearance?

PHASE II THEOPHYLLINE RADIOIMMUNOASSAY received FDA 510(k) clearance on 1984-01-24, under 510(k) number K833789.

Who is the listed applicant for PHASE II THEOPHYLLINE RADIOIMMUNOASSAY?

The FDA 510(k) record lists Medical & Scientific Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHASE II THEOPHYLLINE RADIOIMMUNOASSAY?

The FDA product code for PHASE II THEOPHYLLINE RADIOIMMUNOASSAY is LCA.

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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.