510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771588Substantially Equivalent

Platelet Controls Normal & Abnormal

Dade, Baxter Travenol Diagnostics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771588 is the FDA 510(k) clearance record for PLATELET CONTROLS NORMAL & ABNORMAL, a class II device, cleared for Dade, Baxter Travenol Diagnostics, Inc. on under FDA product code GJP (Control, Platelet). FDA records list 44 510(k) clearances for Dade, Baxter Travenol Diagnostics, Inc., from to . As of , FDA records show no recalls naming K771588.

Clearance record

Decision date
Received
(7 days to decision)
Product code
GJP Control, Platelet
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Dade, Baxter Travenol Diagnostics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GJP

Trailing 12 months

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

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