Device For Sealing Microsections

Device Code: 5011

Product Code(s): KIM

Device Classification Information

• Device Type ID: 5011
• Device Name: Device For Sealing Microsections
• Regulation Description: Device For Sealing Microsections.
• Regulation Medical Specialty: Pathology
• Review Panel: Pathology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 864.3400 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: KIM
• 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: 5011
• Device: Device For Sealing Microsections
• Product Code: KIM
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Device For Sealing Microsections.
• CFR Regulation Number: 864.3400 [🔎]

Device Problems
Appropriate Term/Code Not Available	1
Total Device Problems	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Leica Microsystems, Inc.	II	Oct-03-2018

TPLC Last Update: 2019-04-02 20:58:49