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FDA 510(k)

ABBOTT AXSYM 3RD GENERATION TSH ASSAY

K-Number: K981060 · 1998-04-29

ApplicantAbbott Laboratories
Decision Date1998-04-29
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT AXSYM 3RD GENERATION TSH ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1998-04-29 under 510(k) number K981060. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT AXSYM 3RD GENERATION TSH ASSAY?

ABBOTT AXSYM 3RD GENERATION TSH ASSAY is a medical device that received FDA 510(k) clearance on 1998-04-29. The listed applicant is Abbott Laboratories. The 510(k) number is K981060.

When did ABBOTT AXSYM 3RD GENERATION TSH ASSAY receive FDA 510(k) clearance?

ABBOTT AXSYM 3RD GENERATION TSH ASSAY received FDA 510(k) clearance on 1998-04-29, under 510(k) number K981060.

Who is the listed applicant for ABBOTT AXSYM 3RD GENERATION TSH ASSAY?

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 AXSYM 3RD GENERATION TSH ASSAY?

The FDA product code for ABBOTT AXSYM 3RD GENERATION TSH ASSAY is JLW.

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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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