510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K183648Substantially Equivalent

APAS Independence with Urine Analysis Module

Clever Culture Systems Limited, Bach, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183648 is the FDA 510(k) clearance record for APAS Independence with Urine Analysis Module, a class II device, cleared for Clever Culture Systems AG on under FDA product code PPU (Microbial Colony Image Assessment System). FDA's definition for product code PPU reads: "A microbial colony image assessment system is an instrument that is intended to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, phenotypic and morphologic...". FDA records list 3 510(k) clearances for Clever Culture Systems AG, from to . As of , FDA records show no recalls naming K183648.

Clearance record

Decision date
Received
(140 days to decision)
Product code
PPU Microbial Colony Image Assessment System
Regulation
21 CFR 866.2190
Device class
Class II
Review panel
Microbiology
Applicant
Clever Culture Systems AG Seestrasse 204a, Bach, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PPU

Trailing 12 months
1 clearance under product code PPU in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PPU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260