Counter (beta, Gamma) For Clinical Use

Device Code: 457

Product Code(s): JJJ

Device Classification Information

• Device Type ID: 457
• Device Name: Counter (beta, Gamma) For Clinical Use
• Regulation Description: Beta Or Gamma Counter For Clinical Use.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 862.2320 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JJJ
• 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: 457
• Device: Counter (beta, Gamma) For Clinical Use
• Product Code: JJJ
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Beta Or Gamma Counter For Clinical Use.
• CFR Regulation Number: 862.2320 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Perkinelmer	II	Jan-12-2016
2	Perkinelmer	II	Jul-20-2015

TPLC Last Update: 2019-04-02 19:35:07