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FDA 510(k)

ABBOTT PRISM ANALYZER

K-Number: K940289 · 1994-07-18

ApplicantAbbott Mfg., Inc.
Decision Date1994-07-18
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT PRISM ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Mfg., Inc.. It received FDA 510(k) clearance on 1994-07-18 under 510(k) number K940289. 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 ABBOTT PRISM ANALYZER?

ABBOTT PRISM ANALYZER is a medical device that received FDA 510(k) clearance on 1994-07-18. The listed applicant is Abbott Mfg., Inc.. The 510(k) number is K940289.

When did ABBOTT PRISM ANALYZER receive FDA 510(k) clearance?

ABBOTT PRISM ANALYZER received FDA 510(k) clearance on 1994-07-18, under 510(k) number K940289.

Who is the listed applicant for ABBOTT PRISM ANALYZER?

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

What is the FDA product code for ABBOTT PRISM ANALYZER?

The FDA product code for ABBOTT PRISM ANALYZER is JJE.

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Other records listing Abbott Mfg., 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.

K981457ALBPK981232CAK981231CO2K965230ABBOTT LIFECARE STANDARD TUBING INFUSION PUMPK971293LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVEK953656ABBOTT IMX PROLACTIN(MODIFICATION)

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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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