510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821956Substantially Equivalent

Haem-C Plus Blood Reference Controls

Baker Instructions Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821956 is the FDA 510(k) clearance record for HAEM-C PLUS BLOOD REFERENCE CONTROLS, a class II device, cleared for Baker Instructions Corp. on under FDA product code JCN (Control, Cell Counter, Normal And Abnormal). FDA records list 10 510(k) clearances for Baker Instructions Corp., from to . As of , FDA records show no recalls naming K821956.

Clearance record

Decision date
Received
(30 days to decision)
Product code
JCN Control, Cell Counter, Normal And Abnormal
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Baker Instructions Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JCN

Trailing 12 months

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

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