510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913677Substantially Equivalent

Acs Therapeutic Drug Monit Contols, Level I,ii,iii

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

K913677 is the FDA 510(k) clearance record for ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III, a class I device, cleared for Analytical Control Systems, Inc. on under FDA product code LAS (Drug Specific Control Materials). FDA records list 42 510(k) clearances for Analytical Control Systems, Inc., from to . As of , FDA records show no recalls naming K913677.

Clearance record

Decision date
Received
(37 days to decision)
Product code
LAS Drug Specific Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Analytical Control Systems, Inc. 155 E. Market, Suite 502, Indianapolis IN
510(k) summary
Statement
Third party review
No

Clearances, product code LAS

Trailing 12 months

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

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