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FDA 510(k)

RPR TEST REDITEST

K-Number: K843741 · 1984-10-25

ApplicantBiokit USA, Inc.
Decision Date1984-10-25
Product CodeGMP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RPR TEST REDITEST is the device name listed in this FDA 510(k) record. The listed applicant is Biokit USA, Inc.. It received FDA 510(k) clearance on 1984-10-25 under 510(k) number K843741. The device is classified under product code GMP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RPR TEST REDITEST?

RPR TEST REDITEST is a medical device that received FDA 510(k) clearance on 1984-10-25. The listed applicant is Biokit USA, Inc.. The 510(k) number is K843741.

When did RPR TEST REDITEST receive FDA 510(k) clearance?

RPR TEST REDITEST received FDA 510(k) clearance on 1984-10-25, under 510(k) number K843741.

Who is the listed applicant for RPR TEST REDITEST?

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

What is the FDA product code for RPR TEST REDITEST?

The FDA product code for RPR TEST REDITEST is GMP.

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Other records listing Biokit USA, 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.

K913467TOXOGENK910541BIOKIT RPRK904310RHEUMAGEN RF T-CONTROLK910539RHEUMAJET RFK910686RHEUMAJET CRPK904311RHEUMAGEN ASO T-CONTROL

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Related Devices (Code: GMP)

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.

K980638ADI SYPHILIS RPR LIQUID CONTROLSAmpcor Diagnostics, Inc.K961998QUALITROL SYPHSERO CONTROL SETConsolidated Technologies, Inc.K955143RPR LIQUID CONTROLSRemel, L.P.K885298VISUWELL REAGIN TEST 960 TEST KITAllelix Diagnostics, Inc.K875180V-TREND RPRL CARD TESTTexas Immunology, Inc.K851504VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010Ncs Diagnostics, Inc.

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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