MUELLER HINTON AGAR W/4%NACL AND OXACILLIN

Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth

GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Mueller Hinton Agar W/4%nacl And Oxacillin.

Pre-market Notification Details

• Device ID: K863821
• 510k Number: K863821
• Device Name: MUELLER HINTON AGAR W/4%NACL AND OXACILLIN
• Classification: Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth
• Applicant: GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 2801 INDUSTRIAL DR. Madison, WI 53713
• Contact: Gregg G Burmeister
• Correspondent: Gregg G Burmeister; GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 2801 INDUSTRIAL DR. Madison, WI 53713
• Product Code: JTZ
• CFR Regulation Number: 866.1700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-09-30
• Decision Date: 1986-10-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30382902219522	K863821	000