510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800699Substantially Equivalent

Flo Tem (Fluid Warner)

Chroma Products, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800699 is the FDA 510(k) clearance record for FLO TEM (FLUID WARNER), a class II device, cleared for Chroma Products, Inc. on under FDA product code KZL (Device, Warming. Blood And Plasma). FDA records list one 510(k) clearance for Chroma Products, Inc. As of , FDA records show no recalls naming K800699.

Clearance record

Decision date
Received
(41 days to decision)
Product code
KZL Device, Warming. Blood And Plasma
Regulation
21 CFR 864.9205
Device class
Class II
Review panel
Hematology
Applicant
Chroma Products, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KZL

Trailing 12 months

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

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