510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K842099Substantially Equivalent

Acth Standard Matrix

Diagnostic Systems Laboratories, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842099 is the FDA 510(k) clearance record for ACTH STANDARD MATRIX, a class II device, cleared for Diagnostic Systems Laboratories, Inc. on under FDA product code JIT (Calibrator, Secondary). FDA records list 94 510(k) clearances for Diagnostic Systems Laboratories, Inc., from to . As of , FDA records show no recalls naming K842099.

Clearance record

Decision date
Received
(84 days to decision)
Product code
JIT Calibrator, Secondary
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Diagnostic Systems Laboratories, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JIT

Trailing 12 months

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

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