SPINAL FLUID TOTAL PROTEIN CONTROL

Single (specified) Analyte Controls (assayed And Unassayed)

QUANTIMETRIX CORP.

The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Spinal Fluid Total Protein Control.

Pre-market Notification Details

• Device ID: K831527
• 510k Number: K831527
• Device Name: SPINAL FLUID TOTAL PROTEIN CONTROL
• Classification: Single (specified) Analyte Controls (assayed And Unassayed)
• Applicant: QUANTIMETRIX CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JJX
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-05-12
• Decision Date: 1983-07-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00896863002073	K831527	000
00896863002011	K831527	000
00896863002004	K831527	000