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FDA 510(k)

VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010

K-Number: K851504 · 1985-08-19

ApplicantNcs Diagnostics, Inc.
Decision Date1985-08-19
Product CodeGMP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 is the device name listed in this FDA 510(k) record. The listed applicant is Ncs Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-08-19 under 510(k) number K851504. The device is classified under product code GMP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010?

VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 is a medical device that received FDA 510(k) clearance on 1985-08-19. The listed applicant is Ncs Diagnostics, Inc.. The 510(k) number is K851504.

When did VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 receive FDA 510(k) clearance?

VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 received FDA 510(k) clearance on 1985-08-19, under 510(k) number K851504.

Who is the listed applicant for VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010?

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

What is the FDA product code for VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010?

The FDA product code for VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 is GMP.

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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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