510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K921326Substantially Equivalent

Dade Recomboplastin S

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

K921326 is the FDA 510(k) clearance record for DADE RECOMBOPLASTIN S, a class II device, cleared for Baxter Diagnostics, Inc. on under FDA product code GJS (Test, Time, Prothrombin). FDA records list 72 510(k) clearances for Baxter Diagnostics, Inc., from to . As of , FDA records show no recalls naming K921326.

Clearance record

Decision date
Received
(131 days to decision)
Product code
GJS Test, Time, Prothrombin
Regulation
21 CFR 864.7750
Device class
Class II
Review panel
Hematology
Applicant
Baxter Diagnostics, Inc. P.O.Box 520672, Miami FL
510(k) summary
Summary
Third party review
No

Clearances, product code GJS

Trailing 12 months

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

FDA records show no clearances under product code GJS in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GJS, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260