POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2

Tetraphenyl Borate, Colorimetry, Potassium

RANDOX LABORATORIES, LTD.

The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Potassium Test Kit And Electrolyte Cal 1 And 2.

Pre-market Notification Details

• Device ID: K043267
• 510k Number: K043267
• Device Name: POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2
• Classification: Tetraphenyl Borate, Colorimetry, Potassium
• Applicant: RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy
• Contact: P. Armstrong
• Correspondent: P. Armstrong; RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy
• Product Code: CEJ
• CFR Regulation Number: 862.1600 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-11-26
• Decision Date: 2005-02-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05055273204940	K043267	000
05055273204933	K043267	000