510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K994438Substantially Equivalent

Bilichek Non-Invasive Bilirubin Analyzer

Spectrx, Inc., North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994438 is the FDA 510(k) clearance record for BILICHEK NON-INVASIVE BILIRUBIN ANALYZER, a class I device, cleared for Spectrx, Inc. on under FDA product code MQM (Bilirubin (Total And Unbound) In The Neonate Test System). FDA records list 2 510(k) clearances for Spectrx, Inc., from to . As of , FDA records show no recalls naming K994438.

Clearance record

Decision date
Received
(36 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
Spectrx, Inc. 49 Plain St., North Attleboro 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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MQM, 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