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FDA 510(k)

RUBINDEX*DIRECT SYSTEM

K-Number: K781638 · 1978-12-20

ApplicantOrtho Diagnostics, Inc.
Decision Date1978-12-20
Product CodeGOK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBINDEX*DIRECT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostics, Inc.. It received FDA 510(k) clearance on 1978-12-20 under 510(k) number K781638. The device is classified under product code GOK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBINDEX*DIRECT SYSTEM?

RUBINDEX*DIRECT SYSTEM is a medical device that received FDA 510(k) clearance on 1978-12-20. The listed applicant is Ortho Diagnostics, Inc.. The 510(k) number is K781638.

When did RUBINDEX*DIRECT SYSTEM receive FDA 510(k) clearance?

RUBINDEX*DIRECT SYSTEM received FDA 510(k) clearance on 1978-12-20, under 510(k) number K781638.

Who is the listed applicant for RUBINDEX*DIRECT SYSTEM?

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

What is the FDA product code for RUBINDEX*DIRECT SYSTEM?

The FDA product code for RUBINDEX*DIRECT SYSTEM is GOK.

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Other records listing Ortho Diagnostics, 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.

K802404ORTHO BOVINE ALBUMIN SOLUTION 30% PROTEK801507ANTIGEN CONTROL CELLSK800357BI-LEVEL ASSAYED CARD. DRUG CONT., I,IIK800310ORTHO ANTISERA CONTROLK791791ORTHO ANTIBODY ENHANCEMENT SOLUTIONK791301ORTHO TSH RIA KIT

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Related Devices (Code: GOK)

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.

K832228RUBASCAN LATEX CARD TESTBd Becton Dickinson Vacutainer Systems PreanalyticK810835RUBAZYME - MAbbott LaboratoriesK792635ANTIBODY TO RUBELLA VIRUSElectro-Nucleonics Laboratories, Inc.K792133RUBELISA TEST KITMicrobiological Assoc.K790122RUBANONOrganon, Inc.K781392CYTOMEGILISH TEST KITMicrobiological Assoc.

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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