510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960438Substantially Equivalent

Tintelize Pai-1 Kit

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

K960438 is the FDA 510(k) clearance record for TINTELIZE PAI-1 KIT, a class II device, cleared for Medical Diagnostic Technologies, Inc. on under FDA product code GGP (Test, Qualitative And Quantitative Factor Deficiency). FDA records list 57 510(k) clearances for Medical Diagnostic Technologies, Inc., from to . As of , FDA records show no recalls naming K960438.

Clearance record

Decision date
Received
(126 days to decision)
Product code
GGP Test, Qualitative And Quantitative Factor Deficiency
Regulation
21 CFR 864.7290
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 GGP

Trailing 12 months

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

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