510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032860Substantially Equivalent

Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Iga)

Immco Diagnostics, Inc., Buffalo NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K032860 is the FDA 510(k) clearance record for IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA), a class II device, cleared for Immco Diagnostics, Inc. on under FDA product code NBT (Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)). FDA records list 55 510(k) clearances for Immco Diagnostics, Inc., from to . As of , FDA records show no recalls naming K032860.

Clearance record

Decision date
Received
(188 days to decision)
Product code
NBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
Regulation
21 CFR 866.5785
Device class
Class II
Review panel
Immunology
Applicant
Immco Diagnostics, Inc. 60 Pineview Dr., Buffalo NY
510(k) summary
Statement
Third party review
No

Clearances, product code NBT

Trailing 12 months

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

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