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FDA 510(k)

POSITIVE AND NEGATIVE HCG URINE CONTROLS

K-Number: K894181 · 1989-08-31

ApplicantArmkel, LLC
Decision Date1989-08-31
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

POSITIVE AND NEGATIVE HCG URINE CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1989-08-31 under 510(k) number K894181. 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 POSITIVE AND NEGATIVE HCG URINE CONTROLS?

POSITIVE AND NEGATIVE HCG URINE CONTROLS is a medical device that received FDA 510(k) clearance on 1989-08-31. The listed applicant is Armkel, LLC. The 510(k) number is K894181.

When did POSITIVE AND NEGATIVE HCG URINE CONTROLS receive FDA 510(k) clearance?

POSITIVE AND NEGATIVE HCG URINE CONTROLS received FDA 510(k) clearance on 1989-08-31, under 510(k) number K894181.

Who is the listed applicant for POSITIVE AND NEGATIVE HCG URINE CONTROLS?

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

What is the FDA product code for POSITIVE AND NEGATIVE HCG URINE CONTROLS?

The FDA product code for POSITIVE AND NEGATIVE HCG URINE CONTROLS is 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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