ALBUMIN SCREEN TEST— 510(k) K870516

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K870516 for ALBUMIN SCREEN TEST, Substantially Equivalent on 1987-10-20. Applicant: Sclavo, Inc.. Device class: 1.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code JIQ
Device class: Class 1
Regulation: 21 CFR 862.1645
Advisory panel: Clinical Chemistry
Date received: 1987-02-04
Decision date: 1987-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIQ

K141925 — TOTAL PROTEIN URINE/CSF GEN.32014-12-09
K013643 — AUSAM TOTAL ALBUMIN ASSAY2003-08-14
K991800 — HEMOCHEK URINE COLLECTION KIT1999-09-24
K971458 — ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT1997-09-02
K965035 — IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT1997-04-17

More clearances from Sclavo, Inc.

K914789 — ELISA CMV IGM1992-03-04
K914852 — ELISA TOXO IGM1992-01-23
K914420 — ELISA RUBELLA IGM1991-12-27
K895943 — NORMAL AND ABNORMAL CONTROL SERA1989-12-27
K895822 — TOTAL BILIRUBIN L.F.1989-11-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.