510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070183Substantially Equivalent

Kronus Insulin Autoantibody (Iaa) Assay Kit

Kronus Market Development Associates, Inc., Boise ID / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K070183 is the FDA 510(k) clearance record for KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT, a class II device, cleared for Kronus Market Development Associates, Inc. on under FDA product code OCN (Insulin Autoantibody Kit). FDA's definition for product code OCN reads: "The device is used for the semi-quantitative determination of insulin autoantibodies in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy". FDA records list 11 510(k) clearances for Kronus Market Development Associates, Inc., from to . As of , FDA records show no recalls naming K070183.

Clearance record

Decision date
Received
(175 days to decision)
Product code
OCN Insulin Autoantibody Kit
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Kronus Market Development Associates, Inc. 12554 W. Bridger St., Boise ID
510(k) summary
Statement
Third party review
No

Clearances, product code OCN

Trailing 12 months

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

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