ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002

Single (specified) Analyte Controls (assayed And Unassayed)

EUROTROL B.V.

The following data is part of a premarket notification filed by Eurotrol B.v. with the FDA for Albu Trol, Low, Model 108.001.002; Albu Trol, High 108.002.002.

Pre-market Notification Details

• Device ID: K060215
• 510k Number: K060215
• Device Name: ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002
• Classification: Single (specified) Analyte Controls (assayed And Unassayed)
• Applicant: EUROTROL B.V. 40 EMPIRE DRIVE Lake Forest, CA 92630
• Contact: Allan White
• Correspondent: Allan White; EUROTROL B.V. 40 EMPIRE DRIVE Lake Forest, CA 92630
• Product Code: JJX
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-01-27
• Decision Date: 2006-03-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08718734960638	K060215	000
08718734960614	K060215	000