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FDA 510(k)

AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101

K-Number: K072901 · 2008-07-01

ApplicantAmdl, Inc.
Decision Date2008-07-01
Product CodeNTY
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101 is the device name listed in this FDA 510(k) record. The listed applicant is Amdl, Inc.. It received FDA 510(k) clearance on 2008-07-01 under 510(k) number K072901. The device is classified under product code NTY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101?

AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101 is a medical device that received FDA 510(k) clearance on 2008-07-01. The listed applicant is Amdl, Inc.. The 510(k) number is K072901.

When did AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101 receive FDA 510(k) clearance?

AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101 received FDA 510(k) clearance on 2008-07-01, under 510(k) number K072901.

Who is the listed applicant for AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101?

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

What is the FDA product code for AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101?

The FDA product code for AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101 is NTY.

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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.

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Other records listing Amdl, 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.

K981396PYLORIPROBE

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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