510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955115Substantially Equivalent

Venom Tiem Reagent

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

K955115 is the FDA 510(k) clearance record for VENOM TIEM REAGENT, 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 K955115.

Clearance record

Decision date
Received
(146 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. 6025 Nicolle St., Ventura CA
510(k) summary
Statement
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