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FDA 510(k)

ACCESS R-CLONE ANA PROFILE ASSAY

K-Number: K885048 · 1989-01-24

ApplicantLipogen, Inc.
Decision Date1989-01-24
Product CodeDHC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ACCESS R-CLONE ANA PROFILE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Lipogen, Inc.. It received FDA 510(k) clearance on 1989-01-24 under 510(k) number K885048. The device is classified under product code DHC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESS R-CLONE ANA PROFILE ASSAY?

ACCESS R-CLONE ANA PROFILE ASSAY is a medical device that received FDA 510(k) clearance on 1989-01-24. The listed applicant is Lipogen, Inc.. The 510(k) number is K885048.

When did ACCESS R-CLONE ANA PROFILE ASSAY receive FDA 510(k) clearance?

ACCESS R-CLONE ANA PROFILE ASSAY received FDA 510(k) clearance on 1989-01-24, under 510(k) number K885048.

Who is the listed applicant for ACCESS R-CLONE ANA PROFILE ASSAY?

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 ACCESS R-CLONE ANA PROFILE ASSAY?

The FDA product code for ACCESS R-CLONE ANA PROFILE ASSAY is DHC.

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Other records listing Lipogen, Inc. as applicant

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Related Devices (Code: DHC)

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.

K001352REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KITCorgenix, Inc.K001398REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KITCorgenix, Inc.K930247HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USEThe Binding Site, Ltd.K930421ELIAS DSDNA ABSElias U.S.A., Inc.K914801IMMUNOWELL DSDNA ANTIBODY TESTGeneral Biometrics, Inc.K872910IMMUNO/SLEImmunostics Co., 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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