510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893562Substantially Equivalent

A.qc Hct Level 1 and 2

Johnson & Johnson Professionals, Inc., Roseville MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893562 is the FDA 510(k) clearance record for A.QC HCT LEVEL 1 AND 2, a class II device, cleared for Johnson & Johnson Professionals, Inc. on under FDA product code GLK (Control, Hematocrit). FDA records list 206 510(k) clearances for Johnson & Johnson Professionals, Inc., from to . As of , FDA records show no recalls naming K893562.

Clearance record

Decision date
Received
(66 days to decision)
Product code
GLK Control, Hematocrit
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Johnson & Johnson Professionals, Inc. 2675 Long Lake Rd., Roseville MN
Third party review
No

Clearances, product code GLK

Trailing 12 months

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

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