510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982879Substantially Equivalent

Shield Diastat Anti-B2 Glycoprotein 1 Igg (Elisa) Assay

Shield Diagnostics, Ltd., Dundee, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982879 is the FDA 510(k) clearance record for SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY, a class II device, cleared for Shield Diagnostics, Ltd. on under FDA product code MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)). FDA records list 27 510(k) clearances for Shield Diagnostics, Ltd., from to . As of , FDA records show one recall naming K982879.

Clearance record

Decision date
Received
(62 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
Shield Diagnostics, Ltd. The Technology Park, Dundee, GB
510(k) summary
Statement
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