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FDA 510(k)

DAC-CEL PTH KIT RD51

K-Number: K831069 · 1983-06-16

ApplicantWellcome Diagnostics
Decision Date1983-06-16
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DAC-CEL PTH KIT RD51 is the device name listed in this FDA 510(k) record. The listed applicant is Wellcome Diagnostics. It received FDA 510(k) clearance on 1983-06-16 under 510(k) number K831069. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAC-CEL PTH KIT RD51?

DAC-CEL PTH KIT RD51 is a medical device that received FDA 510(k) clearance on 1983-06-16. The listed applicant is Wellcome Diagnostics. The 510(k) number is K831069.

When did DAC-CEL PTH KIT RD51 receive FDA 510(k) clearance?

DAC-CEL PTH KIT RD51 received FDA 510(k) clearance on 1983-06-16, under 510(k) number K831069.

Who is the listed applicant for DAC-CEL PTH KIT RD51?

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

What is the FDA product code for DAC-CEL PTH KIT RD51?

The FDA product code for DAC-CEL PTH KIT RD51 is CEW.

Other records listing Wellcome Diagnostics as applicant

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Related Devices (Code: CEW)

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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