SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015-

Manual Antimicrobial Susceptibility Test Systems

TDS HOLDINGS INC.

The following data is part of a premarket notification filed by Tds Holdings Inc. with the FDA for Susceptibility Test Plate For Ertapenem 0.002-16ug/ml For Gram Negative. Susceptibility Test Plate For Ertapenem 0.015-.

Pre-market Notification Details

• Device ID: K060621
• 510k Number: K060621
• Device Name: SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015-
• Classification: Manual Antimicrobial Susceptibility Test Systems
• Applicant: TDS HOLDINGS INC. 982 KEYNOTE CIRCLE, SUITE 6 Cleveland, OH 44131
• Contact: Cynthia C Knapp
• Correspondent: Cynthia C Knapp; TDS HOLDINGS INC. 982 KEYNOTE CIRCLE, SUITE 6 Cleveland, OH 44131
• Product Code: JWY
• CFR Regulation Number: 866.1640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-03-08
• Decision Date: 2006-04-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M578GN3F2	K060621	000