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FDA 510(k)

ON CALL MULTI-DRUG HOME TEST CUP

K-Number: K050878 · 2005-06-08

ApplicantACON Laboratories, Inc.
Decision Date2005-06-08
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ON CALL MULTI-DRUG HOME TEST CUP is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2005-06-08 under 510(k) number K050878. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ON CALL MULTI-DRUG HOME TEST CUP?

ON CALL MULTI-DRUG HOME TEST CUP is a medical device that received FDA 510(k) clearance on 2005-06-08. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K050878.

When did ON CALL MULTI-DRUG HOME TEST CUP receive FDA 510(k) clearance?

ON CALL MULTI-DRUG HOME TEST CUP received FDA 510(k) clearance on 2005-06-08, under 510(k) number K050878.

Who is the listed applicant for ON CALL MULTI-DRUG HOME TEST CUP?

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

What is the FDA product code for ON CALL MULTI-DRUG HOME TEST CUP?

The FDA product code for ON CALL MULTI-DRUG HOME TEST CUP is LDJ.

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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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