510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880989Substantially Equivalent

Ats Cryptosporidium Stain Set

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

K880989 is the FDA 510(k) clearance record for ATS CRYPTOSPORIDIUM STAIN SET, a class I device, cleared for Alpha-Tec Systems, Inc. on under FDA product code JTS (Stains, Microbiologic). FDA records list 18 510(k) clearances for Alpha-Tec Systems, Inc., from to . As of , FDA records show no recalls naming K880989.

Clearance record

Decision date
Received
(66 days to decision)
Product code
JTS Stains, Microbiologic
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Alpha-Tec Systems, Inc. 18271 Mcdurmott W., Suite I, Irvine CA
Third party review
No

Clearances, product code JTS

Trailing 12 months

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

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