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FDA 510(k)

SD CHECK GOLD

K-Number: K082683 · 2009-12-08

ApplicantStandard Diagnostics, Inc.
Decision Date2009-12-08
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SD CHECK GOLD is the device name listed in this FDA 510(k) record. The listed applicant is Standard Diagnostics, Inc.. It received FDA 510(k) clearance on 2009-12-08 under 510(k) number K082683. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SD CHECK GOLD?

SD CHECK GOLD is a medical device that received FDA 510(k) clearance on 2009-12-08. The listed applicant is Standard Diagnostics, Inc.. The 510(k) number is K082683.

When did SD CHECK GOLD receive FDA 510(k) clearance?

SD CHECK GOLD received FDA 510(k) clearance on 2009-12-08, under 510(k) number K082683.

Who is the listed applicant for SD CHECK GOLD?

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

What is the FDA product code for SD CHECK GOLD?

The FDA product code for SD CHECK GOLD is NBW. This falls under the OB/GYN category.

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Other records listing Standard Diagnostics, Inc. as applicant

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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Related Devices (Code: NBW)

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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