510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093623Substantially Equivalent

Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem Cvp 2 (Addition of Total Bilirubim Assignment to

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

K093623 is the FDA 510(k) clearance record for GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO, a class II device, cleared for Instrumentation Laboratory CO on under FDA product code CIG (Diazo Colorimetry, Bilirubin). FDA records list 327 510(k) clearances for Instrumentation Laboratory CO, from to . As of , FDA records show 5 recalls naming K093623.

Clearance record

Decision date
Received
(207 days to decision)
Product code
CIG Diazo Colorimetry, Bilirubin
Regulation
21 CFR 862.1110
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Instrumentation Laboratory CO 180 Hartwell Ave., Bedford MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CIG

Trailing 12 months
1 clearance under product code CIG 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 CIG, 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