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FDA 510(k)

RF CARD TEST & RF LIQUID TEST

K-Number: K880164 · 1988-02-10

ApplicantAmpcor, Inc.
Decision Date1988-02-10
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RF CARD TEST & RF LIQUID TEST is the device name listed in this FDA 510(k) record. The listed applicant is Ampcor, Inc.. It received FDA 510(k) clearance on 1988-02-10 under 510(k) number K880164. 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 CARD TEST & RF LIQUID TEST?

RF CARD TEST & RF LIQUID TEST is a medical device that received FDA 510(k) clearance on 1988-02-10. The listed applicant is Ampcor, Inc.. The 510(k) number is K880164.

When did RF CARD TEST & RF LIQUID TEST receive FDA 510(k) clearance?

RF CARD TEST & RF LIQUID TEST received FDA 510(k) clearance on 1988-02-10, under 510(k) number K880164.

Who is the listed applicant for RF CARD TEST & RF LIQUID TEST?

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

What is the FDA product code for RF CARD TEST & RF LIQUID TEST?

The FDA product code for RF CARD TEST & RF LIQUID TEST is DHR.

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Other records listing Ampcor, Inc. as applicant

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K922296IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TESTK922297INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TESTK910438DIPSTICK SALMONELLAK893873SINGLE AND DUAL BAND DIPSTICK HCG TESTK890048QUIK-DOT TOXOPLASMOSISK892146C REACTIVE PROTEIN LIQUID

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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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