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FDA 510(k)

BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM

K-Number: K011970 · 2001-09-26

ApplicantBiosafe Laboratories, Inc.
Decision Date2001-09-26
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM 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 2001-09-26 under 510(k) number K011970. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM?

BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM is a medical device that received FDA 510(k) clearance on 2001-09-26. The listed applicant is Biosafe Laboratories, Inc.. The 510(k) number is K011970.

When did BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM receive FDA 510(k) clearance?

BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM received FDA 510(k) clearance on 2001-09-26, under 510(k) number K011970.

Who is the listed applicant for BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM?

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 BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM?

The FDA product code for BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM is CHH.

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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.

K042379ANEMIAPRO SELF-SCREENERK012221SAFE AT HOME 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: CHH)

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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