510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K980646Substantially Equivalent

Il Synthesis--Addition of Bilirubin as a Measured Parameter for Neonate Whole Blood Samples

Instrumentation Laboratory Co., Lexington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980646 is the FDA 510(k) clearance record for IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES, a class I device, cleared for Instrumentation Laboratory CO on under FDA product code MQM (Bilirubin (Total And Unbound) In The Neonate Test System). FDA records list 327 510(k) clearances for Instrumentation Laboratory CO, from to . As of , FDA records show no recalls naming K980646.

Clearance record

Decision date
Received
(76 days to decision)
Product code
MQM Bilirubin (Total And Unbound) In The Neonate Test System
Regulation
21 CFR 862.1113
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Instrumentation Laboratory CO 113 Hartwell Ave., Lexington MA
510(k) summary
Summary
Third party review
No

Clearances, product code MQM

Trailing 12 months

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

FDA records show no clearances under product code MQM in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MQM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260