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FDA 510(k)

DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS

K-Number: K772098 · 1977-12-20

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1977-12-20
Product CodeDON
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1977-12-20 under 510(k) number K772098. 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 DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS?

DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS is a medical device that received FDA 510(k) clearance on 1977-12-20. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K772098.

When did DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS receive FDA 510(k) clearance?

DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS received FDA 510(k) clearance on 1977-12-20, under 510(k) number K772098.

Who is the listed applicant for DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS?

The FDA product code for DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS is DON.

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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 & ScientificK830533PHASE II DIGOXIN RADIOIMMUNOASSAY KITMedical & Scientific Designs, Inc.K822053ZETAPHASE-DIGBiological & Diagnostic ProductsK821000ENZYMUNE-TEST DIGOXINIcl Scientific

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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