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FDA 510(k)

HGB3 (1:251)

K-Number: K802266 · 1980-10-23

ApplicantR&D Systems, Inc.
Decision Date1980-10-23
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HGB3 (1:251) is the device name listed in this FDA 510(k) record. The listed applicant is R&D Systems, Inc.. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K802266. 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 HGB3 (1:251)?

HGB3 (1:251) is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is R&D Systems, Inc.. The 510(k) number is K802266.

When did HGB3 (1:251) receive FDA 510(k) clearance?

HGB3 (1:251) received FDA 510(k) clearance on 1980-10-23, under 510(k) number K802266.

Who is the listed applicant for HGB3 (1:251)?

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

What is the FDA product code for HGB3 (1:251)?

The FDA product code for HGB3 (1:251) is GKR.

Other records listing R&D Systems, 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.

K160606BC-5D Hematology ControlK130962R&D 5D RETIC HEMATOLOGY CONTROLK101578R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROLK100050R & D SYSTEMS XERET HEMATOLOGY CONTROLK091433R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROLK073178HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004

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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 GmbHK163465hemochroma PLUS SystemImmunostics 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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