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FDA 510(k)

BIOTRACK HEMOGLOBIN TEST CARTRIDGE

K-Number: K895101 · 1989-10-10

ApplicantBiotrack, Inc.
Decision Date1989-10-10
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIOTRACK HEMOGLOBIN TEST CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Biotrack, Inc.. It received FDA 510(k) clearance on 1989-10-10 under 510(k) number K895101. 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 BIOTRACK HEMOGLOBIN TEST CARTRIDGE?

BIOTRACK HEMOGLOBIN TEST CARTRIDGE is a medical device that received FDA 510(k) clearance on 1989-10-10. The listed applicant is Biotrack, Inc.. The 510(k) number is K895101.

When did BIOTRACK HEMOGLOBIN TEST CARTRIDGE receive FDA 510(k) clearance?

BIOTRACK HEMOGLOBIN TEST CARTRIDGE received FDA 510(k) clearance on 1989-10-10, under 510(k) number K895101.

Who is the listed applicant for BIOTRACK HEMOGLOBIN TEST CARTRIDGE?

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

What is the FDA product code for BIOTRACK HEMOGLOBIN TEST CARTRIDGE?

The FDA product code for BIOTRACK HEMOGLOBIN TEST CARTRIDGE is KHG.

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Other records listing Biotrack, 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.

K934062BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLSK934061BIOTRACK VALPROIC ACID TEST CARTRIDGEK920525BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROLK915756BIOTRACK CARBAMAZEPINE TEST CARTRIDGEK915755BIOTRACK PHENYTOIN TEST CARTRIDGEK903924BIOTRACK THEOPHYLLINE QUALITY CONTROLS

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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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