510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K822897Substantially Equivalent

Dsl 1700

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

K822897 is the FDA 510(k) clearance record for DSL 1700, a class II device, cleared for Diagnostic Systems Laboratories, Inc. on under FDA product code JHW (U.V. Method, Cpk Isoenzymes). FDA records list 94 510(k) clearances for Diagnostic Systems Laboratories, Inc., from to . As of , FDA records show no recalls naming K822897.

Clearance record

Decision date
Received
(78 days to decision)
Product code
JHW U.V. Method, Cpk Isoenzymes
Regulation
21 CFR 862.1215
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 JHW

Trailing 12 months

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

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