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FDA 510(k)

ANEMIAPRO SELF-SCREENER

K-Number: K042379 · 2004-12-15

ApplicantBiosafe Laboratories, Inc.
Decision Date2004-12-15
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ANEMIAPRO SELF-SCREENER is the device name listed in this FDA 510(k) record. The listed applicant is Biosafe Laboratories, Inc.. It received FDA 510(k) clearance on 2004-12-15 under 510(k) number K042379. 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 ANEMIAPRO SELF-SCREENER?

ANEMIAPRO SELF-SCREENER is a medical device that received FDA 510(k) clearance on 2004-12-15. The listed applicant is Biosafe Laboratories, Inc.. The 510(k) number is K042379.

When did ANEMIAPRO SELF-SCREENER receive FDA 510(k) clearance?

ANEMIAPRO SELF-SCREENER received FDA 510(k) clearance on 2004-12-15, under 510(k) number K042379.

Who is the listed applicant for ANEMIAPRO SELF-SCREENER?

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

What is the FDA product code for ANEMIAPRO SELF-SCREENER?

The FDA product code for ANEMIAPRO SELF-SCREENER is KHG.

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Other records listing Biosafe Laboratories, 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.

K012221SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEMK011970BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEMK011525SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)K003752BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)K991850SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC

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, LLCK020138STAT-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, 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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