510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864212Substantially Equivalent

Il Test 97573-15, Plasminogen Assay

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

K864212 is the FDA 510(k) clearance record for IL TEST 97573-15, PLASMINOGEN ASSAY, a class I device, cleared for Instrumentation Laboratory CO on under FDA product code DDX (Plasminogen, Antigen, Antiserum, Control). FDA records list 327 510(k) clearances for Instrumentation Laboratory CO, from to . As of , FDA records show no recalls naming K864212.

Clearance record

Decision date
Received
(37 days to decision)
Product code
DDX Plasminogen, Antigen, Antiserum, Control
Regulation
21 CFR 866.5715
Device class
Class I
Review panel
Immunology
Applicant
Instrumentation Laboratory CO 113 Hartwell Ave., Lexington MA
Third party review
No

Clearances, product code DDX

Trailing 12 months

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

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