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FDA 510(k)

IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM

K-Number: K952490 · 1995-12-15

ApplicantRoche Image Analysis Systems
Decision Date1995-12-15
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Roche Image Analysis Systems. It received FDA 510(k) clearance on 1995-12-15 under 510(k) number K952490. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM?

IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM is a medical device that received FDA 510(k) clearance on 1995-12-15. The listed applicant is Roche Image Analysis Systems. The 510(k) number is K952490.

When did IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM receive FDA 510(k) clearance?

IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM received FDA 510(k) clearance on 1995-12-15, under 510(k) number K952490.

Who is the listed applicant for IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM?

The FDA 510(k) record lists Roche Image Analysis Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM?

The FDA product code for IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM is LJM.

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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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