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FDA 510(k)

HEMOGLOBIN CONTROL LEVELS

K-Number: K801268 · 1980-07-14

ApplicantBioscientific
Decision Date1980-07-14
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOGLOBIN CONTROL LEVELS is the device name listed in this FDA 510(k) record. The listed applicant is Bioscientific. It received FDA 510(k) clearance on 1980-07-14 under 510(k) number K801268. 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 CONTROL LEVELS?

HEMOGLOBIN CONTROL LEVELS is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is Bioscientific. The 510(k) number is K801268.

When did HEMOGLOBIN CONTROL LEVELS receive FDA 510(k) clearance?

HEMOGLOBIN CONTROL LEVELS received FDA 510(k) clearance on 1980-07-14, under 510(k) number K801268.

Who is the listed applicant for HEMOGLOBIN CONTROL LEVELS?

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

What is the FDA product code for HEMOGLOBIN CONTROL LEVELS?

The FDA product code for HEMOGLOBIN CONTROL LEVELS is KHG.

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Other records listing Bioscientific 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.

K812447AMYLASE REAGENT KITK811251CITRATE BUFFERK801267RED BLOOD CELL COUNT & HEMATOCRIT CNTLK801265WHITE BLOOD CELL COUNT CONTROL LEVELSK791658WRIGHT STAIN PACKK791007STAT DIFF STAIN

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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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