510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K061879Substantially Equivalent

Sdi Ca480 Clinical Chemistry System; Saturno 300 Clinical Chemistry System

Hemodiagnostica, LLC, Johns Island SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061879 is the FDA 510(k) clearance record for SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM, a class II device, cleared for Hemodiagnostica, LLC on under FDA product code CFR (Hexokinase, Glucose). FDA records list one 510(k) clearance for Hemodiagnostica, LLC. As of , FDA records show no recalls naming K061879.

Clearance record

Decision date
Received
(165 days to decision)
Product code
CFR Hexokinase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Hemodiagnostica, LLC 130 Gardeners Cir., Johns Island SC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CFR

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