510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970505Substantially Equivalent

Dade Pfa-100 Platelet Function Analyzer/pfa Collagen/epinephrine Test Cartridge/pfa Collagen/adp Test Cartridge/

Dade Intl., Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970505 is the FDA 510(k) clearance record for DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/, a class II device, cleared for Dade Intl., Inc. on under FDA product code JOZ (System, Automated Platelet Aggregation). FDA records list 30 510(k) clearances for Dade Intl., Inc., from to . As of , FDA records show no recalls naming K970505.

Clearance record

Decision date
Received
(280 days to decision)
Product code
JOZ System, Automated Platelet Aggregation
Regulation
21 CFR 864.5700
Device class
Class II
Review panel
Hematology
Applicant
Dade Intl., Inc. 2173 NW 99th Ave., Miami FL
510(k) summary
Summary
Third party review
No

Clearances, product code JOZ

Trailing 12 months

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

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