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FDA 510(k)

CATALOGUE NUMBER 321-07/15/50

K-Number: K945243 · 1995-02-08

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1995-02-08
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CATALOGUE NUMBER 321-07/15/50 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 1995-02-08 under 510(k) number K945243. The device is classified under product code JFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATALOGUE NUMBER 321-07/15/50?

CATALOGUE NUMBER 321-07/15/50 is a medical device that received FDA 510(k) clearance on 1995-02-08. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K945243.

When did CATALOGUE NUMBER 321-07/15/50 receive FDA 510(k) clearance?

CATALOGUE NUMBER 321-07/15/50 received FDA 510(k) clearance on 1995-02-08, under 510(k) number K945243.

Who is the listed applicant for CATALOGUE NUMBER 321-07/15/50?

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

What is the FDA product code for CATALOGUE NUMBER 321-07/15/50?

The FDA product code for CATALOGUE NUMBER 321-07/15/50 is JFJ.

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Related Devices (Code: JFJ)

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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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