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FDA 510(k)

LABSYSTEMS FP-901 CHEMISTRY ANALYZER

K-Number: K842773 · 1984-09-04

ApplicantLabsystems, Inc.
Decision Date1984-09-04
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LABSYSTEMS FP-901 CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Labsystems, Inc.. It received FDA 510(k) clearance on 1984-09-04 under 510(k) number K842773. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LABSYSTEMS FP-901 CHEMISTRY ANALYZER?

LABSYSTEMS FP-901 CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1984-09-04. The listed applicant is Labsystems, Inc.. The 510(k) number is K842773.

When did LABSYSTEMS FP-901 CHEMISTRY ANALYZER receive FDA 510(k) clearance?

LABSYSTEMS FP-901 CHEMISTRY ANALYZER received FDA 510(k) clearance on 1984-09-04, under 510(k) number K842773.

Who is the listed applicant for LABSYSTEMS FP-901 CHEMISTRY ANALYZER?

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 FP-901 CHEMISTRY ANALYZER?

The FDA product code for LABSYSTEMS FP-901 CHEMISTRY ANALYZER is JJE.

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Other records listing Labsystems, Inc. as applicant

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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: JJE)

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

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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