Who is the manufacturer of MODIFICATION OF ABL MIC-10 PRECEPT SYS?

Austin Biological Laboratories filed the 510(k) submission for MODIFICATION OF ABL MIC-10 PRECEPT SYS (K843612).

What is the FDA product code for MODIFICATION OF ABL MIC-10 PRECEPT SYS?

LTD. as a Class 3 device in the MI panel.

What is the regulatory pathway for MODIFICATION OF ABL MIC-10 PRECEPT SYS?

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

Who can help prepare an FDA 510(k) submission like MODIFICATION OF ABL MIC-10 PRECEPT SYS?

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.

MODIFICATION OF ABL MIC-10 PRECEPT SYS

K843612 · Austin Biological Laboratories · LTD · Feb 19, 1985 · MI

Device Facts

Record ID	K843612
Device Name	MODIFICATION OF ABL MIC-10 PRECEPT SYS
Applicant	Austin Biological Laboratories
Product Code	LTD · MI
Decision Date	Feb 19, 1985
Decision	SESE
Submission Type	Traditional
Device Class	Class 3

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