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FDA 510(k)

ABBOTT IMX 2 ANALYZER

K-Number: K944731 · 1994-12-19

ApplicantAbbott Laboratories
Decision Date1994-12-19
Product CodeJJI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT IMX 2 ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1994-12-19 under 510(k) number K944731. The device is classified under product code JJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT IMX 2 ANALYZER?

ABBOTT IMX 2 ANALYZER is a medical device that received FDA 510(k) clearance on 1994-12-19. The listed applicant is Abbott Laboratories. The 510(k) number is K944731.

When did ABBOTT IMX 2 ANALYZER receive FDA 510(k) clearance?

ABBOTT IMX 2 ANALYZER received FDA 510(k) clearance on 1994-12-19, under 510(k) number K944731.

Who is the listed applicant for ABBOTT IMX 2 ANALYZER?

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

What is the FDA product code for ABBOTT IMX 2 ANALYZER?

The FDA product code for ABBOTT IMX 2 ANALYZER is JJI.

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Other records listing Abbott Laboratories 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.

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Related Devices (Code: JJI)

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.

K972024CODA AUTOMATED EIA ANALYZERBio-RadK931970ABBOTT IMX2 ANALYERAbbott LaboratoriesK930898RADIAS AUTOMATED IMMUNOASSAY SYSTEMBio-RadK790073ANALYZER, IMPACT 100Gilford Instrument Laboratories, Inc.K780972QUICKRATE REACTION RATE ANALYZEROlympus Corp.K771591MINISTAT-S CHEMISTRY ANALYZERBiokinetix Corp.

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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