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FDA 510(k)

MODIFICATION OF: DAVIDSTRIP HCG

K-Number: K991067 · 1999-04-27

ApplicantSimex Medical, Inc.
Decision Date1999-04-27
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF: DAVIDSTRIP HCG is the device name listed in this FDA 510(k) record. The listed applicant is Simex Medical, Inc.. It received FDA 510(k) clearance on 1999-04-27 under 510(k) number K991067. 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 MODIFICATION OF: DAVIDSTRIP HCG?

MODIFICATION OF: DAVIDSTRIP HCG is a medical device that received FDA 510(k) clearance on 1999-04-27. The listed applicant is Simex Medical, Inc.. The 510(k) number is K991067.

When did MODIFICATION OF: DAVIDSTRIP HCG receive FDA 510(k) clearance?

MODIFICATION OF: DAVIDSTRIP HCG received FDA 510(k) clearance on 1999-04-27, under 510(k) number K991067.

Who is the listed applicant for MODIFICATION OF: DAVIDSTRIP HCG?

The FDA 510(k) record lists Simex Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION OF: DAVIDSTRIP HCG?

The FDA product code for MODIFICATION OF: DAVIDSTRIP 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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