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FDA 510(k)

RF DIPSTICK TEST KIT

K-Number: K874151 · 1987-12-29

ApplicantLipogen, Inc.
Decision Date1987-12-29
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RF DIPSTICK TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Lipogen, Inc.. It received FDA 510(k) clearance on 1987-12-29 under 510(k) number K874151. 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 RF DIPSTICK TEST KIT?

RF DIPSTICK TEST KIT is a medical device that received FDA 510(k) clearance on 1987-12-29. The listed applicant is Lipogen, Inc.. The 510(k) number is K874151.

When did RF DIPSTICK TEST KIT receive FDA 510(k) clearance?

RF DIPSTICK TEST KIT received FDA 510(k) clearance on 1987-12-29, under 510(k) number K874151.

Who is the listed applicant for RF DIPSTICK TEST KIT?

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

What is the FDA product code for RF DIPSTICK TEST KIT?

The FDA product code for RF DIPSTICK TEST KIT is DHR.

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Other records listing Lipogen, 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.

K902636LIPOGEN RHEUMELISA DSDNA ASSAYK895997RHEUMELISA ASSAY FOR RNP AUTOANTIBODIESK895996RHEUMELISA ASSAY FOR SM AUTOANTIBODIESK895995RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIESK895994RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIESK894659ANA ANTISERA CONTROL KIT

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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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