510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982301Substantially Equivalent

Micro21 with Urine Sediment Analysis

Triangle Biomedical Sciences, Inc., Palm Beach Gardens FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982301 is the FDA 510(k) clearance record for MICRO21 WITH URINE SEDIMENT ANALYSIS, a class II device, cleared for Triangle Biomedical Sciences, Inc. on under FDA product code JOY (Device, Automated Cell-Locating). FDA records list 6 510(k) clearances for Triangle Biomedical Sciences, Inc., from to . As of , FDA records show no recalls naming K982301.

Clearance record

Decision date
Received
(37 days to decision)
Product code
JOY Device, Automated Cell-Locating
Regulation
21 CFR 864.5260
Device class
Class II
Review panel
Hematology
Applicant
Triangle Biomedical Sciences, Inc. 4360 Northlake Blvd., #214, Palm Beach Gardens FL
510(k) summary
Summary
Third party review
No

Clearances, product code JOY

Trailing 12 months

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

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