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FDA 510(k)

DAC-CEL DIAGNATAL HCG STANDARDS RD49

K-Number: K830204 · 1983-02-18

ApplicantWellcome Diagnostics
Decision Date1983-02-18
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DAC-CEL DIAGNATAL HCG STANDARDS RD49 is the device name listed in this FDA 510(k) record. The listed applicant is Wellcome Diagnostics. It received FDA 510(k) clearance on 1983-02-18 under 510(k) number K830204. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAC-CEL DIAGNATAL HCG STANDARDS RD49?

DAC-CEL DIAGNATAL HCG STANDARDS RD49 is a medical device that received FDA 510(k) clearance on 1983-02-18. The listed applicant is Wellcome Diagnostics. The 510(k) number is K830204.

When did DAC-CEL DIAGNATAL HCG STANDARDS RD49 receive FDA 510(k) clearance?

DAC-CEL DIAGNATAL HCG STANDARDS RD49 received FDA 510(k) clearance on 1983-02-18, under 510(k) number K830204.

Who is the listed applicant for DAC-CEL DIAGNATAL HCG STANDARDS RD49?

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 DIAGNATAL HCG STANDARDS RD49?

The FDA product code for DAC-CEL DIAGNATAL HCG STANDARDS RD49 is JJX.

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Related Devices (Code: JJX)

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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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