510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153137Substantially Equivalent

HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls

Instrumentation Laboratory Co., Bedford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153137 is the FDA 510(k) clearance record for HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls, a class II device, cleared for Instrumentation Laboratory CO on under FDA product code LCO (Platelet Factor 4 Radioimmunoassay). FDA records list 327 510(k) clearances for Instrumentation Laboratory CO, from to . As of , FDA records show no recalls naming K153137.

Clearance record

Decision date
Received
(252 days to decision)
Product code
LCO Platelet Factor 4 Radioimmunoassay
Regulation
21 CFR 864.7695
Device class
Class II
Review panel
Hematology
Applicant
Instrumentation Laboratory CO 180 Hartwell Rd., Bedford MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LCO

Trailing 12 months

FDA records hold no clearances under product code LCO in the trailing twelve months.

FDA records show no clearances under product code LCO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LCO, 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