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FDA 510(k)

DCL SYPHILIS-M CATALOG NO. 600-80

K-Number: K895964 · 1991-01-08

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1991-01-08
Product CodeLIP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DCL SYPHILIS-M CATALOG NO. 600-80 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 1991-01-08 under 510(k) number K895964. 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-M CATALOG NO. 600-80?

DCL SYPHILIS-M CATALOG NO. 600-80 is a medical device that received FDA 510(k) clearance on 1991-01-08. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K895964.

When did DCL SYPHILIS-M CATALOG NO. 600-80 receive FDA 510(k) clearance?

DCL SYPHILIS-M CATALOG NO. 600-80 received FDA 510(k) clearance on 1991-01-08, under 510(k) number K895964.

Who is the listed applicant for DCL SYPHILIS-M CATALOG NO. 600-80?

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-M CATALOG NO. 600-80?

The FDA product code for DCL SYPHILIS-M CATALOG NO. 600-80 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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