510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K220163Substantially Equivalent

Her-2, ER, PR IHControls

Boston Cell Standards Inc, Sharon MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220163 is the FDA 510(k) clearance record for Her-2, ER, PR IHControls, a class II device, cleared for Boston Cell Standards, Inc. on under FDA product code NJW (Control Material, Her-2/Neu, Immunohistochemistry). FDA's definition for product code NJW reads: "Accessory to immunohistochemistry assays for Her2-neu. Control material intended for laboratory use to control Her2-neu immunohistochemistry assays". FDA records list one 510(k) clearance for Boston Cell Standards, Inc. As of , FDA records show no recalls naming K220163.

Clearance record

Decision date
Received
(207 days to decision)
Product code
NJW Control Material, Her-2/Neu, Immunohistochemistry
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Applicant
Boston Cell Standards, Inc. 35 Cheryl Dr., Sharon MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NJW

Trailing 12 months

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

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