510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K900147Substantially Equivalent

Modified Dsl-2300 Acth Ria

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

K900147 is the FDA 510(k) clearance record for MODIFIED DSL-2300 ACTH RIA, a class II device, cleared for Diagnostic Systems Laboratories, Inc. on under FDA product code CKG (Radioimmunoassay, Acth). FDA records list 94 510(k) clearances for Diagnostic Systems Laboratories, Inc., from to . As of , FDA records show no recalls naming K900147.

Clearance record

Decision date
Received
(49 days to decision)
Product code
CKG Radioimmunoassay, Acth
Regulation
21 CFR 862.1025
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Diagnostic Systems Laboratories, Inc. 445 Medical Center Blvd., Webster TX
Third party review
No

Clearances, product code CKG

Trailing 12 months

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

FDA records show no clearances under product code CKG in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CKG, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260