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FDA 510(k)

QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)

K-Number: K896271 · 1989-11-08

ApplicantBiokit USA, Inc.
Decision Date1989-11-08
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) 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 1989-11-08 under 510(k) number K896271. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)?

QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) is a medical device that received FDA 510(k) clearance on 1989-11-08. The listed applicant is Biokit USA, Inc.. The 510(k) number is K896271.

When did QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) receive FDA 510(k) clearance?

QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) received FDA 510(k) clearance on 1989-11-08, under 510(k) number K896271.

Who is the listed applicant for QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)?

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 QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)?

The FDA product code for QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) is DHR.

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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: DHR)

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.

K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)Kamiya Biomedical CompanyK190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsInova Diagnostics, Inc.K182747EliA RF IgM ImmunoassayPhadia ABK162263Optilite Rheumatoid Factor KitThe Binding Site Group , Ltd.K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group , Ltd.K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMPhadia US, 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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