510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921637Substantially Equivalent

Esp Blood Culture System

Difco Laboratories, Inc., Ann Arbor MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921637 is the FDA 510(k) clearance record for ESP BLOOD CULTURE SYSTEM, a class I device, cleared for Difco Laboratories, Inc. on under FDA product code MDB (System, Blood Culturing). FDA records list 121 510(k) clearances for Difco Laboratories, Inc., from to . As of , FDA records show no recalls naming K921637.

Clearance record

Decision date
Received
(99 days to decision)
Product code
MDB System, Blood Culturing
Regulation
21 CFR 866.2560
Device class
Class I
Review panel
Microbiology
Applicant
Difco Laboratories, Inc. 1180 Ellsworth Rd., Ann Arbor MI
510(k) summary
Summary
Third party review
No

Clearances, product code MDB

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