SULFOSALICYLIC ACID, 3% W/V

Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)

E K IND., INC.

The following data is part of a premarket notification filed by E K Ind., Inc. with the FDA for Sulfosalicylic Acid, 3% W/v.

Pre-market Notification Details

• Device ID: K842915
• 510k Number: K842915
• Device Name: SULFOSALICYLIC ACID, 3% W/V
• Classification: Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)
• Applicant: E K IND., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JIQ
• CFR Regulation Number: 862.1645 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-07-25
• Decision Date: 1984-08-10