510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911177Substantially Equivalent

Acs Therapeutic Drug Monitoring Control, Level II

Analytical Control Systems, Fishers IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911177 is the FDA 510(k) clearance record for ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II, a class I device, cleared for Analytical Control Systems, Inc. on under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)). FDA records list 42 510(k) clearances for Analytical Control Systems, Inc., from to . As of , FDA records show no recalls naming K911177.

Clearance record

Decision date
Received
(44 days to decision)
Product code
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Analytical Control Systems, Inc. 9058 Technology Dr., Fishers IN
Third party review
No

Clearances, product code JJX

Trailing 12 months

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

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