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FDA 510(k)

DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70

K-Number: K895965 · 1990-12-26

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1990-12-26
Product CodeLIP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1990-12-26 under 510(k) number K895965. The device is classified under product code LIP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70?

DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 is a medical device that received FDA 510(k) clearance on 1990-12-26. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K895965.

When did DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 receive FDA 510(k) clearance?

DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 received FDA 510(k) clearance on 1990-12-26, under 510(k) number K895965.

Who is the listed applicant for DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70?

The FDA 510(k) record lists Diagnostic Chemicals, Ltd. (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70?

The FDA product code for DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 is LIP.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) as applicant

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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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