510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K821675Substantially Equivalent

Calcitonin Ria Test Kit, Dls 1200

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

K821675 is the FDA 510(k) clearance record for CALCITONIN RIA TEST KIT, DLS 1200, a class II device, cleared for Diagnostic Systems Laboratories, Inc. on under FDA product code JKR (Radioimmunoassay, Calcitonin). FDA records list 94 510(k) clearances for Diagnostic Systems Laboratories, Inc., from to . As of , FDA records show no recalls naming K821675.

Clearance record

Decision date
Received
(14 days to decision)
Product code
JKR Radioimmunoassay, Calcitonin
Regulation
21 CFR 862.1140
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Diagnostic Systems Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JKR

Trailing 12 months
1 clearance under product code JKR in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JKR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260