510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K983172Substantially Equivalent

Accu-Base Hemoglobin A1c Sample Collection Kit

Diabetes Technologies, Inc. (Dti), Thomasville GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983172 is the FDA 510(k) clearance record for ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT, a class II device, cleared for Diabetes Technologies, Inc. (Dti) on under FDA product code LCP (Assay, Glycosylated Hemoglobin). FDA records list one 510(k) clearance for Diabetes Technologies, Inc. (Dti). As of , FDA records show no recalls naming K983172.

Clearance record

Decision date
Received
(81 days to decision)
Product code
LCP Assay, Glycosylated Hemoglobin
Regulation
21 CFR 864.7470
Device class
Class II
Review panel
Hematology
Applicant
Diabetes Technologies, Inc. (Dti) 216 W. Jackson St., Thomasville GA
510(k) summary
Summary
Third party review
No

Clearances, product code LCP

Trailing 12 months

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

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