Who is the manufacturer of REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS?

Syva Co. filed the 510(k) submission for REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS (K874626).

What is the FDA product code for REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS?

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

What is the regulatory pathway for REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS?

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

Who can help prepare an FDA 510(k) submission like REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS?

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 SYVA PHENCYCLIDINE ASSAYS

K874626 · Syva Co. · LCL · Jan 11, 1988 · TX

Device Facts

Record ID	K874626
Device Name	REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS
Applicant	Syva Co.
Product Code	LCL · TX
Decision Date	Jan 11, 1988
Decision	SESE
Submission Type	Traditional
Device Class	Class U

REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS

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