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FDA 510(k)

ELIAS DSDNA ABS

K-Number: K930421 · 1993-03-10

ApplicantElias U.S.A., Inc.
Decision Date1993-03-10
Product CodeDHC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ELIAS DSDNA ABS is the device name listed in this FDA 510(k) record. The listed applicant is Elias U.S.A., Inc.. It received FDA 510(k) clearance on 1993-03-10 under 510(k) number K930421. 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 ELIAS DSDNA ABS?

ELIAS DSDNA ABS is a medical device that received FDA 510(k) clearance on 1993-03-10. The listed applicant is Elias U.S.A., Inc.. The 510(k) number is K930421.

When did ELIAS DSDNA ABS receive FDA 510(k) clearance?

ELIAS DSDNA ABS received FDA 510(k) clearance on 1993-03-10, under 510(k) number K930421.

Who is the listed applicant for ELIAS DSDNA ABS?

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

What is the FDA product code for ELIAS DSDNA ABS?

The FDA product code for ELIAS DSDNA ABS is DHC.

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Other records listing Elias U.S.A., 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.

K964385ELIAS ANA-HEP-2K963291VARELISA ANA (4) PROFILEK953873VARELISA HELICOBACTER PYLORI ANTIBODIESK953587VARELISA MPO-ANCAK953586VARELISA PR3-ANCAK951187VARELISA CARDIOLIPIN ABS SCREEN

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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.K914801IMMUNOWELL DSDNA ANTIBODY TESTGeneral Biometrics, Inc.K885048ACCESS R-CLONE ANA PROFILE ASSAYLipogen, 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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