ClearanceBrief
Company ยท US

Instrumentation Laboratory (IL) Co.

FDA 510(k) clearances and medical device recalls filed under this name, 2024 to 2026. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
GFOActivated Partial Thromboplastin1
GGWTest, Time, Partial Thromboplastin1
GKPInstrument, Coagulation, Automated1
KQJSystem, Fibrinogen Determination1
LCOPlatelet Factor 4 Radioimmunoassay1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Mar 20, 2026K260551HemosIL Factor V Leiden (APC Resistance V)
Instrumentation Laboratory (IL) Co.
GGW
Jan 9, 2026K253957HemosIL Silica Clotting Time
Instrumentation Laboratory (IL) Co.
GFO
Jul 24, 2025K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL
Instrumentation Laboratory (IL) Co.
KQJ
Jan 28, 2025K243374HemosIL CL HIT-IgG(PF4-H)
Instrumentation Laboratory (IL) Co.
LCO
Aug 16, 2024K242127ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)
Instrumentation Laboratory (IL) Co.
GKP

Latest recalls

DateFirm and productCodeLinked 510(k)
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