510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971464Substantially Equivalent

Immunoscan Anti-Gbm Quantitative Kit

Svar Life Science AB, Ringoes NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971464 is the FDA 510(k) clearance record for IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT, a class II device, cleared for Euro-Diagnostica AB on under FDA product code DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control). FDA records list 6 510(k) clearances for Svar Life Science AB, from to . As of , FDA records show no recalls naming K971464.

Clearance record

Decision date
Received
(190 days to decision)
Product code
DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Euro-Diagnostica AB 155 Cider Mill Rd., Ringoes NJ
510(k) summary
Statement
Third party review
No

Clearances, product code DBL

Trailing 12 months

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

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