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FDA 510(k)

NRBC-CHEX FOR ADVIA

K-Number: K080016 · 2008-02-05

ApplicantStreck
Decision Date2008-02-05
Product CodeGJR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

NRBC-CHEX FOR ADVIA is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2008-02-05 under 510(k) number K080016. The device is classified under product code GJR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NRBC-CHEX FOR ADVIA?

NRBC-CHEX FOR ADVIA is a medical device that received FDA 510(k) clearance on 2008-02-05. The listed applicant is Streck. The 510(k) number is K080016.

When did NRBC-CHEX FOR ADVIA receive FDA 510(k) clearance?

NRBC-CHEX FOR ADVIA received FDA 510(k) clearance on 2008-02-05, under 510(k) number K080016.

Who is the listed applicant for NRBC-CHEX FOR ADVIA?

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

What is the FDA product code for NRBC-CHEX FOR ADVIA?

The FDA product code for NRBC-CHEX FOR ADVIA is GJR.

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Other records listing Streck 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.

K254166MDx-Chex for BCNK231221MDx-Chex for BC-GPK231223MDx-Chex for BC-GNK170091UA-Cellular CompleteK160585XN CALK160590XN CHECK

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Related Devices (Code: GJR)

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.

K060083NRBC-CHEX FOR LHStreckK000076CELL-CHEXStreck Laboratories, Inc.K940430SEDRATROLMedical Specialties Intl., Inc.K900484RET-CHECKStreck Laboratories, 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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