Container, Specimen Mailer And Storage, Non-sterile

Device Code: 5025

Product Code(s): NNK

Device Classification Information

• Device Type ID: 5025
• Device Name: Container, Specimen Mailer And Storage, Non-sterile
• Regulation Description: Specimen Transport And Storage Container.
• 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: 864.3250 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: NNK
• GMP Exempt: Yes
• 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: 5025
• Device: Container, Specimen Mailer And Storage, Non-sterile
• Product Code: NNK
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Specimen Transport And Storage Container.
• CFR Regulation Number: 864.3250 [🔎]

Device Problems
Device Contamination With Chemical Or Other Material	1
Incorrect Or Inadequate Test Results	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 20:59:01