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FDA 510(k)

LABSYSTEMS UNISKAN

K-Number: K841214 · 1984-04-13

ApplicantLabsystems, Inc.
Decision Date1984-04-13
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LABSYSTEMS UNISKAN is the device name listed in this FDA 510(k) record. The listed applicant is Labsystems, Inc.. It received FDA 510(k) clearance on 1984-04-13 under 510(k) number K841214. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LABSYSTEMS UNISKAN?

LABSYSTEMS UNISKAN is a medical device that received FDA 510(k) clearance on 1984-04-13. The listed applicant is Labsystems, Inc.. The 510(k) number is K841214.

When did LABSYSTEMS UNISKAN receive FDA 510(k) clearance?

LABSYSTEMS UNISKAN received FDA 510(k) clearance on 1984-04-13, under 510(k) number K841214.

Who is the listed applicant for LABSYSTEMS UNISKAN?

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

What is the FDA product code for LABSYSTEMS UNISKAN?

The FDA product code for LABSYSTEMS UNISKAN is JJQ.

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Other records listing Labsystems, 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.

K923365TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEMK896474RESUBMITTED FECATWIN SENSITIVE - FECA-EIAK890154MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIAK890091MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KITK881243RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201K873780MODIFICATION RUBELLA IGM EIA TEST KIT

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Related Devices (Code: JJQ)

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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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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