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FDA 510(k)

HEMOGLOBIN REAGENT

K-Number: K823060 · 1982-11-22

ApplicantBiorent Diagnostic, Inc.
Decision Date1982-11-22
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOGLOBIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Biorent Diagnostic, Inc.. It received FDA 510(k) clearance on 1982-11-22 under 510(k) number K823060. 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 HEMOGLOBIN REAGENT?

HEMOGLOBIN REAGENT is a medical device that received FDA 510(k) clearance on 1982-11-22. The listed applicant is Biorent Diagnostic, Inc.. The 510(k) number is K823060.

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

HEMOGLOBIN REAGENT received FDA 510(k) clearance on 1982-11-22, under 510(k) number K823060.

Who is the listed applicant for HEMOGLOBIN REAGENT?

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

What is the FDA product code for HEMOGLOBIN REAGENT?

The FDA product code for HEMOGLOBIN REAGENT is KHG.

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Other records listing Biorent Diagnostic, 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.

K832747ALBUMIN REAGENT SETK823211CK-UV REAGENTK822494OPTIMIZED UV-GPT REAGENT SETK822493OPTIMIZED UV-GOT REAGENT SETK822492OPTIMIZED UV-LDH REAGENT SETK820768COLORIMETRIC LDH REAGENT SET

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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 TechnologyK001462CARESIDE HEMOGLOBINCareside, Inc.K994073HEMOSITE 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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