Media And Components, Synthetic Cell And Tissue Culture

Device Code: 4841

Product Code(s): KIT

Device Classification Information

• Device Type ID: 4841
• Device Name: Media And Components, Synthetic Cell And Tissue Culture
• Regulation Description: Synthetic Cell And Tissue Culture Media And Components.
• Regulation Medical Specialty: Hematology
• Review Panel: Pathology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 864.2220 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: KIT
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 4841
• Device: Media And Components, Synthetic Cell And Tissue Culture
• Product Code: KIT
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Synthetic Cell And Tissue Culture Media And Components.
• CFR Regulation Number: 864.2220 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Life Technologies, Corp.	II	Oct-17-2018

TPLC Last Update: 2019-04-02 20:56:19