510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890148Substantially Equivalent

Ats Tb Rapid Stain Set Product #034-45

Alpha-Tec Systems, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890148 is the FDA 510(k) clearance record for ATS TB RAPID STAIN SET PRODUCT #034-45, a class I device, cleared for Alpha-Tec Systems, Inc. on under FDA product code ICL (Carbol Fuchsin). FDA records list 18 510(k) clearances for Alpha-Tec Systems, Inc., from to . As of , FDA records show no recalls naming K890148.

Clearance record

Decision date
Received
(11 days to decision)
Product code
ICL Carbol Fuchsin
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Alpha-Tec Systems, Inc. P.O. Box 17196, Irvine CA
Third party review
No

Clearances, product code ICL

Trailing 12 months

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

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