Who is the manufacturer of REVISED LABELING FOR PCP TEST KIT?

Roche Diagnostic Systems, Inc. filed the 510(k) submission for REVISED LABELING FOR PCP TEST KIT (K874267).

What is the FDA product code for REVISED LABELING FOR PCP TEST KIT?

LCM. as a Class U device in the TX panel.

What is the regulatory pathway for REVISED LABELING FOR PCP TEST KIT?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like REVISED LABELING FOR PCP TEST KIT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

REVISED LABELING FOR PCP TEST KIT

K874267 · Roche Diagnostic Systems, Inc. · LCM · Nov 13, 1987 · TX

Device Facts

Record ID	K874267
Device Name	REVISED LABELING FOR PCP TEST KIT
Applicant	Roche Diagnostic Systems, Inc.
Product Code	LCM · TX
Decision Date	Nov 13, 1987
Decision	SESE
Submission Type	Traditional
Device Class	Class U

REVISED LABELING FOR PCP TEST KIT

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