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FDA 510(k)

AXSYM TOTAL B-HCG

K-Number: K935673 · 1994-06-21

ApplicantAbbott Laboratories
Decision Date1994-06-21
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AXSYM TOTAL B-HCG is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1994-06-21 under 510(k) number K935673. 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 AXSYM TOTAL B-HCG?

AXSYM TOTAL B-HCG is a medical device that received FDA 510(k) clearance on 1994-06-21. The listed applicant is Abbott Laboratories. The 510(k) number is K935673.

When did AXSYM TOTAL B-HCG receive FDA 510(k) clearance?

AXSYM TOTAL B-HCG received FDA 510(k) clearance on 1994-06-21, under 510(k) number K935673.

Who is the listed applicant for AXSYM TOTAL B-HCG?

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 AXSYM TOTAL B-HCG?

The FDA product code for AXSYM TOTAL B-HCG 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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