510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K884618Substantially Equivalent

Nova Celltrak 11 Auto. Hema. Analyzer, Calibrators

Nova Biomedical Corporation, Walham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884618 is the FDA 510(k) clearance record for NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS, a class II device, cleared for Nova Biomedical Corp. on under FDA product code GKL (Counter, Cell, Automated (Particle Counter)). FDA records list 129 510(k) clearances for Nova Biomedical Corp., from to . As of , FDA records show no recalls naming K884618.

Clearance record

Decision date
Received
(81 days to decision)
Product code
GKL Counter, Cell, Automated (Particle Counter)
Regulation
21 CFR 864.5200
Device class
Class II
Review panel
Hematology
Applicant
Nova Biomedical Corp. 200 Prospect St., Walham MA
Third party review
No

Clearances, product code GKL

Trailing 12 months

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

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