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FDA 510(k)

ABBOTT TESTPACK PLUS HCG COMBO WITH OBC

K-Number: K965116 · 1997-02-20

ApplicantAbbott Laboratories
Decision Date1997-02-20
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT TESTPACK PLUS HCG COMBO WITH OBC is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1997-02-20 under 510(k) number K965116. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT TESTPACK PLUS HCG COMBO WITH OBC?

ABBOTT TESTPACK PLUS HCG COMBO WITH OBC is a medical device that received FDA 510(k) clearance on 1997-02-20. The listed applicant is Abbott Laboratories. The 510(k) number is K965116.

When did ABBOTT TESTPACK PLUS HCG COMBO WITH OBC receive FDA 510(k) clearance?

ABBOTT TESTPACK PLUS HCG COMBO WITH OBC received FDA 510(k) clearance on 1997-02-20, under 510(k) number K965116.

Who is the listed applicant for ABBOTT TESTPACK PLUS HCG COMBO WITH OBC?

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 PLUS HCG COMBO WITH OBC?

The FDA product code for ABBOTT TESTPACK PLUS HCG COMBO WITH OBC is JHI.

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Related Devices (Code: JHI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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