510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896033Substantially Equivalent

Fdp Collection Tubes

Medical Diagnostic Technologies, Inc., Ventura CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896033 is the FDA 510(k) clearance record for FDP COLLECTION TUBES, a class II device, cleared for Medical Diagnostic Technologies, Inc. on under FDA product code JCO (Bothrops Atrox Reagent). FDA records list 57 510(k) clearances for Medical Diagnostic Technologies, Inc., from to . As of , FDA records show no recalls naming K896033.

Clearance record

Decision date
Received
(11 days to decision)
Product code
JCO Bothrops Atrox Reagent
Regulation
21 CFR 864.8100
Device class
Class II
Review panel
Hematology
Applicant
Medical Diagnostic Technologies, Inc. 6020 Nicolle St., Suite D, Ventura CA
Third party review
No

Clearances, product code JCO

Trailing 12 months

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

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