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FDA 510(k)

ABBOTT ARCHITECT LH CALIBRATORS

K-Number: K111023 · 2011-06-10

ApplicantAbbott Laboratories
Decision Date2011-06-10
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT ARCHITECT LH CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2011-06-10 under 510(k) number K111023. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT ARCHITECT LH CALIBRATORS?

ABBOTT ARCHITECT LH CALIBRATORS is a medical device that received FDA 510(k) clearance on 2011-06-10. The listed applicant is Abbott Laboratories. The 510(k) number is K111023.

When did ABBOTT ARCHITECT LH CALIBRATORS receive FDA 510(k) clearance?

ABBOTT ARCHITECT LH CALIBRATORS received FDA 510(k) clearance on 2011-06-10, under 510(k) number K111023.

Who is the listed applicant for ABBOTT ARCHITECT LH CALIBRATORS?

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 ARCHITECT LH CALIBRATORS?

The FDA product code for ABBOTT ARCHITECT LH CALIBRATORS is JIT.

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Related Devices (Code: JIT)

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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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