510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K870516Substantially Equivalent

Albumin Screen Test

Sclavo, Inc., Wayne NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870516 is the FDA 510(k) clearance record for ALBUMIN SCREEN TEST, a class I device, cleared for Sclavo, Inc. on under FDA product code JIQ (Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)). FDA records list 82 510(k) clearances for Sclavo, Inc., from to . As of , FDA records show no recalls naming K870516.

Clearance record

Decision date
Received
(258 days to decision)
Product code
JIQ Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Regulation
21 CFR 862.1645
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Sclavo, Inc. 5 Mansard Ct., Wayne NJ
Third party review
No

Clearances, product code JIQ

Trailing 12 months

FDA records hold no clearances under product code JIQ in the trailing twelve months.

FDA records show no clearances under product code JIQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JIQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260