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FDA 510(k)

LIFE LINE

K-Number: K830254 · 1983-05-18

ApplicantKb & Assoc.
Decision Date1983-05-18
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFE LINE is the device name listed in this FDA 510(k) record. The listed applicant is Kb & Assoc.. It received FDA 510(k) clearance on 1983-05-18 under 510(k) number K830254. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFE LINE?

LIFE LINE is a medical device that received FDA 510(k) clearance on 1983-05-18. The listed applicant is Kb & Assoc.. The 510(k) number is K830254.

When did LIFE LINE receive FDA 510(k) clearance?

LIFE LINE received FDA 510(k) clearance on 1983-05-18, under 510(k) number K830254.

Who is the listed applicant for LIFE LINE?

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

What is the FDA product code for LIFE LINE?

The FDA product code for LIFE LINE is DXH. This falls under the Hematology category.

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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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