510(k) K842915
K842915 is an FDA 510(k) premarket notification submitted by E K Ind., Inc. for the device "SULFOSALICYLIC ACID, 3% W/V". The FDA issued a decision of Substantially Equivalent on August 10, 1984. The device falls under product code JIQ (Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1645. E K Ind., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 1984
- Date Received
- July 25, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
- Device Class
- Class I
- Regulation Number
- 862.1645
- Review Panel
- CH
- Submission Type