510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870089Substantially Equivalent

Immunoscan(tm) Direct Neisseria Meningitidis Kit

Microscan Div. Baxter Healthcare Corp., West Sacramento CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870089 is the FDA 510(k) clearance record for IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT, a class II device, cleared for Microscan Div. Baxter Healthcare Corp. on under FDA product code GTJ (Antisera, All Groups, N. Meningitidis). FDA records list 11 510(k) clearances for Microscan Div. Baxter Healthcare Corp., from to . As of , FDA records show no recalls naming K870089.

Clearance record

Decision date
Received
(67 days to decision)
Product code
GTJ Antisera, All Groups, N. Meningitidis
Regulation
21 CFR 866.3390
Device class
Class II
Review panel
Microbiology
Applicant
Microscan Div. Baxter Healthcare Corp. 2040 Enterprise Blvd., West Sacramento CA
Third party review
No

Clearances, product code GTJ

Trailing 12 months

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

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