510(k) K822231

ACA URINARY PROTEIN ANALYTICAL TEST PACK by E.I. Dupont DE Nemours & Co., Inc. — Product Code JGQ

K822231 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "ACA URINARY PROTEIN ANALYTICAL TEST PACK". The FDA issued a decision of Substantially Equivalent on September 30, 1982. The device falls under product code JGQ (Turbidimetric, Total Protein), a Class II device regulated under 21 CFR 862.1635. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1982
Date Received
July 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Turbidimetric, Total Protein
Device Class
Class II
Regulation Number
862.1635
Review Panel
CH
Submission Type