510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K943981Substantially Equivalent

Il Test Phenobarbital Calibrators

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

K943981 is the FDA 510(k) clearance record for IL TEST PHENOBARBITAL CALIBRATORS, a class II device, cleared for Instrumentation Laboratory CO on under FDA product code DLZ (Enzyme Immunoassay, Phenobarbital). FDA records list 327 510(k) clearances for Instrumentation Laboratory CO, from to . As of , FDA records show no recalls naming K943981.

Clearance record

Decision date
Received
(225 days to decision)
Product code
DLZ Enzyme Immunoassay, Phenobarbital
Regulation
21 CFR 862.3660
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Instrumentation Laboratory CO 101 Hartwell Ave., Lexington MA
510(k) summary
Summary
Third party review
No

Clearances, product code DLZ

Trailing 12 months

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

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