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
K812212Substantially Equivalent

Acridine Orange Stain

Carr-Scarborough Microbiologicals, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812212 is the FDA 510(k) clearance record for ACRIDINE ORANGE STAIN, a class I device, cleared for Carr-Scarborough Microbiologicals, Inc. on under FDA product code IDC (Acridine Orange). FDA records list 24 510(k) clearances for Carr-Scarborough Microbiologicals, Inc., from to . As of , FDA records show no recalls naming K812212.

Clearance record

Decision date
Received
(27 days to decision)
Product code
IDC Acridine Orange
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Carr-Scarborough Microbiologicals, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IDC

Trailing 12 months

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

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