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FDA 510(k)

BIOSAMPLER

K-Number: K844615 · 1985-03-21

ApplicantBiotek-Caribbean
Decision Date1985-03-21
Product CodeCBT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIOSAMPLER is the device name listed in this FDA 510(k) record. The listed applicant is Biotek-Caribbean. It received FDA 510(k) clearance on 1985-03-21 under 510(k) number K844615. The device is classified under product code CBT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSAMPLER?

BIOSAMPLER is a medical device that received FDA 510(k) clearance on 1985-03-21. The listed applicant is Biotek-Caribbean. The 510(k) number is K844615.

When did BIOSAMPLER receive FDA 510(k) clearance?

BIOSAMPLER received FDA 510(k) clearance on 1985-03-21, under 510(k) number K844615.

Who is the listed applicant for BIOSAMPLER?

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

What is the FDA product code for BIOSAMPLER?

The FDA product code for BIOSAMPLER is CBT.

Related Clinical Trials

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.

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Related Devices (Code: CBT)

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.

K071269HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.K070340SECURE ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.K955663ABC IN-LINE BLOOD SAMPLING KITUtah Medical Products, Inc.K954015ABG POINT LOK NEEDLE PROTECTION DEVICEDevon Industries, Inc.K954035ACTI-FLEX ARTERIAL EXTENSION SETR-Group Intl.K950098NEEDLE SAFETY COVERHammer-Plane, Inc.

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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