510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930267Substantially Equivalent

Biomerieux Uniplasmatrol Normal & Abnormal

Biomerieux Vitek, Inc., Hazelwood MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930267 is the FDA 510(k) clearance record for BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL, a class II device, cleared for Biomerieux Vitek, Inc. on under FDA product code GGC (Control, Plasma, Abnormal). FDA records list 49 510(k) clearances for Biomerieux Vitek, Inc., from to . As of , FDA records show no recalls naming K930267.

Clearance record

Decision date
Received
(427 days to decision)
Product code
GGC Control, Plasma, Abnormal
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
Biomerieux Vitek, Inc. 595 Anglum Dr., Hazelwood MO
510(k) summary
Summary
Third party review
No

Clearances, product code GGC

Trailing 12 months

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

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