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FDA 510(k)

hemochroma PLUS System

K-Number: K163465 · 2017-09-08

ApplicantImmunostics Inc.,
Decision Date2017-09-08
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

hemochroma PLUS System is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Inc.,. It received FDA 510(k) clearance on 2017-09-08 under 510(k) number K163465. The device is classified under product code GKR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the hemochroma PLUS System?

hemochroma PLUS System is a medical device that received FDA 510(k) clearance on 2017-09-08. The listed applicant is Immunostics Inc.,. The 510(k) number is K163465.

When did hemochroma PLUS System receive FDA 510(k) clearance?

hemochroma PLUS System received FDA 510(k) clearance on 2017-09-08, under 510(k) number K163465.

Who is the listed applicant for hemochroma PLUS System?

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

What is the FDA product code for hemochroma PLUS System?

The FDA product code for hemochroma PLUS System is GKR.

Other records listing Immunostics 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.

K221817ALFIS Vitamin D, ALFIS-3 AnalyzerK182298hemochroma PLUS SystemK163225AFIAS iFOB with AFIAS-50K171484hema-screen SPECIFIC GoldK163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test

Related Devices (Code: GKR)

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.

K201217HemoCue Hb 301 SystemHemocue ABK200909Hemo Control (optional Add Pack Hemo Control DM)Ekf-Diagnostic GmbHK181751HemoCue Hb 801 SystemHemocue ABK182298hemochroma PLUS SystemImmunostics Inc.,K172173DiaSpect Tm, DiaSpect Tm CuvettesEkf-Diagnostic GmbH

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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