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FDA 510(k)

HEMOCUE PHOTOMETER TECHNICAL MANUAL

K-Number: K832020 · 1983-10-28

ApplicantAktiebolaget Leo Diagnostics
Decision Date1983-10-28
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCUE PHOTOMETER TECHNICAL MANUAL is the device name listed in this FDA 510(k) record. The listed applicant is Aktiebolaget Leo Diagnostics. It received FDA 510(k) clearance on 1983-10-28 under 510(k) number K832020. 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 HEMOCUE PHOTOMETER TECHNICAL MANUAL?

HEMOCUE PHOTOMETER TECHNICAL MANUAL is a medical device that received FDA 510(k) clearance on 1983-10-28. The listed applicant is Aktiebolaget Leo Diagnostics. The 510(k) number is K832020.

When did HEMOCUE PHOTOMETER TECHNICAL MANUAL receive FDA 510(k) clearance?

HEMOCUE PHOTOMETER TECHNICAL MANUAL received FDA 510(k) clearance on 1983-10-28, under 510(k) number K832020.

Who is the listed applicant for HEMOCUE PHOTOMETER TECHNICAL MANUAL?

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

What is the FDA product code for HEMOCUE PHOTOMETER TECHNICAL MANUAL?

The FDA product code for HEMOCUE PHOTOMETER TECHNICAL MANUAL is GKR.

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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

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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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