510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013643Substantially Equivalent

Ausam Total Albumin Assay

Ausam Biotecthnologies, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013643 is the FDA 510(k) clearance record for AUSAM TOTAL ALBUMIN ASSAY, a class I device, cleared for Ausam Biotecthnologies, Inc. on under FDA product code JIQ (Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)). FDA records list one 510(k) clearance for Ausam Biotecthnologies, Inc. As of , FDA records show no recalls naming K013643.

Clearance record

Decision date
Received
(647 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
Ausam Biotecthnologies, Inc. 50 Rockefeller Plz., New York NY
510(k) summary
Statement
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