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FDA 510(k)

ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT

K-Number: K863099 · 1986-09-16

ApplicantAbbott Laboratories
Decision Date1986-09-16
Product CodeJJK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL 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 1986-09-16 under 510(k) number K863099. The device is classified under product code JJK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT?

ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT is a medical device that received FDA 510(k) clearance on 1986-09-16. The listed applicant is Abbott Laboratories. The 510(k) number is K863099.

When did ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT receive FDA 510(k) clearance?

ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT received FDA 510(k) clearance on 1986-09-16, under 510(k) number K863099.

Who is the listed applicant for ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL 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 TESTPACK (TM) ACUTE HEP A CONTROL KIT?

The FDA product code for ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT is JJK.

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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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