510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162788Substantially Equivalent

ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA

Immco Diagnostics, Inc., Clarence NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162788 is the FDA 510(k) clearance record for ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA, a class II device, cleared for Immco Diagnostics, Inc. on under FDA product code MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)). FDA records list 55 510(k) clearances for Immco Diagnostics, Inc., from to . As of , FDA records show no recalls naming K162788.

Clearance record

Decision date
Received
(259 days to decision)
Product code
MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Immco Diagnostics, Inc. 9870 Hollingson Rd., Clarence NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MSV

Trailing 12 months
1 clearance under product code MSV 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 MSV, 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