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FDA 510(k)

S-TEST CA

K-Number: K072356 · 2008-06-24

ApplicantAlfa Wassermann Diagnostic Technologies, Inc.
Decision Date2008-06-24
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

S-TEST CA is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Wassermann Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 2008-06-24 under 510(k) number K072356. The device is classified under product code CJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-TEST CA?

S-TEST CA is a medical device that received FDA 510(k) clearance on 2008-06-24. The listed applicant is Alfa Wassermann Diagnostic Technologies, Inc.. The 510(k) number is K072356.

When did S-TEST CA receive FDA 510(k) clearance?

S-TEST CA received FDA 510(k) clearance on 2008-06-24, under 510(k) number K072356.

Who is the listed applicant for S-TEST CA?

The FDA 510(k) record lists Alfa Wassermann Diagnostic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S-TEST CA?

The FDA product code for S-TEST CA is CJY.

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Related Devices (Code: CJY)

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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