510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801909Substantially Equivalent

Lsa 290 Assay Reagents/nephelometric

J.T. Baker Chemical Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801909 is the FDA 510(k) clearance record for LSA 290 ASSAY REAGENTS/NEPHELOMETRIC, a class I device, cleared for J.T. Baker Chemical Co. on under FDA product code DEX (Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control). FDA records list 54 510(k) clearances for J.T. Baker Chemical Co., from to . As of , FDA records show no recalls naming K801909.

Clearance record

Decision date
Received
(46 days to decision)
Product code
DEX Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control
Regulation
21 CFR 866.5420
Device class
Class I
Review panel
Immunology
Applicant
J.T. Baker Chemical Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DEX

Trailing 12 months

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

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