Enzymatic Methods, Galactose

Device Code: 429

Product Code(s): JIA

Device Classification Information

• Device Type ID: 429
• Device Name: Enzymatic Methods, Galactose
• Regulation Description: Galactose Test System.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 862.1310 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JIA
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 429
• Device: Enzymatic Methods, Galactose
• Product Code: JIA
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Galactose Test System.
• CFR Regulation Number: 862.1310 [🔎]

Premarket Reviews
Manufacturer	Decision
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

TPLC Last Update: 2019-04-02 19:34:31