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FDA 510(k)

CARESIDE HEMOGLOBIN

K-Number: K001462 · 2000-08-21

ApplicantCareside, Inc.
Decision Date2000-08-21
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CARESIDE HEMOGLOBIN is the device name listed in this FDA 510(k) record. The listed applicant is Careside, Inc.. It received FDA 510(k) clearance on 2000-08-21 under 510(k) number K001462. The device is classified under product code KHG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARESIDE HEMOGLOBIN?

CARESIDE HEMOGLOBIN is a medical device that received FDA 510(k) clearance on 2000-08-21. The listed applicant is Careside, Inc.. The 510(k) number is K001462.

When did CARESIDE HEMOGLOBIN receive FDA 510(k) clearance?

CARESIDE HEMOGLOBIN received FDA 510(k) clearance on 2000-08-21, under 510(k) number K001462.

Who is the listed applicant for CARESIDE HEMOGLOBIN?

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

What is the FDA product code for CARESIDE HEMOGLOBIN?

The FDA product code for CARESIDE HEMOGLOBIN is KHG.

Related Clinical Trials

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 Careside, 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.

K020484CARESIDE LDHK020486CARESIDE GGTK020487CARESIDE ALTK020488CARESIDE TRGLYCERIDEK002792CARESIDE CHOLINESTERASEK993771CARESIDE DIRECT BILIRUBIN

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Related Devices (Code: KHG)

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.

K221508AnemoCheck HomeSanguina, Inc.K163215AnemoCheckSanguina, LLCK042379ANEMIAPRO SELF-SCREENERBiosafe Laboratories, Inc.K020138STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090Gds TechnologyK994073HEMOSITE TEST SYSTEMGds Technology, LLCK973649HEMOSITE TEST SYSTEMGds Technology, LLC

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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