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FDA 510(k)

PHASE II DIGOXIN RADIOIMMUNOASSAY KIT

K-Number: K830533 · 1983-04-05

ApplicantMedical & Scientific Designs, Inc.
Decision Date1983-04-05
Product CodeDON
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PHASE II DIGOXIN RADIOIMMUNOASSAY KIT 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 1983-04-05 under 510(k) number K830533. The device is classified under product code DON. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHASE II DIGOXIN RADIOIMMUNOASSAY KIT?

PHASE II DIGOXIN RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1983-04-05. The listed applicant is Medical & Scientific Designs, Inc.. The 510(k) number is K830533.

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

PHASE II DIGOXIN RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1983-04-05, under 510(k) number K830533.

Who is the listed applicant for PHASE II DIGOXIN RADIOIMMUNOASSAY KIT?

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 DIGOXIN RADIOIMMUNOASSAY KIT?

The FDA product code for PHASE II DIGOXIN RADIOIMMUNOASSAY KIT is DON.

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Other records listing Medical & Scientific Designs, 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.

K862960PHASE II FERRITIN RADIOIMMUNOASSAY KITK853224PHASE II B-12/FOLATE KITK840901PHASE II FREE T4 KITK840328PHASE II HCG KITK834219PHASE II CORTISOL KITK833789PHASE II THEOPHYLLINE RADIOIMMUNOASSAY

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Related Devices (Code: DON)

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.

K902861CIBA CORNING ACS DIGOXIN IMMUNOASSAYCiba Corning Diagnostics Corp.K881679CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAYCiba Corning Diagnostics Corp.K840461MAGIC 125I DIGOXIN RADIOIMMUNOASSAYCorning Medical & ScientificK822053ZETAPHASE-DIGBiological & Diagnostic ProductsK821000ENZYMUNE-TEST DIGOXINIcl ScientificK810296DIGOXIN RIA ASSAYRia 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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