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FDA 510(k)

ABBOTT HTSH EIA DIAGNOSTIC KIT

K-Number: K843540 · 1984-11-02

ApplicantAbbott Laboratories
Decision Date1984-11-02
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT HTSH EIA DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1984-11-02 under 510(k) number K843540. 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 HTSH EIA DIAGNOSTIC KIT?

ABBOTT HTSH EIA DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1984-11-02. The listed applicant is Abbott Laboratories. The 510(k) number is K843540.

When did ABBOTT HTSH EIA DIAGNOSTIC KIT receive FDA 510(k) clearance?

ABBOTT HTSH EIA DIAGNOSTIC KIT received FDA 510(k) clearance on 1984-11-02, under 510(k) number K843540.

Who is the listed applicant for ABBOTT HTSH EIA DIAGNOSTIC KIT?

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 HTSH EIA DIAGNOSTIC KIT?

The FDA product code for ABBOTT HTSH EIA DIAGNOSTIC KIT is JLW.

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Related Devices (Code: 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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