510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K864544Substantially Equivalent

Diabetes Risk Detector

Pearce Clinical Laboratories, Inc., Conroe TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864544 is the FDA 510(k) clearance record for DIABETES RISK DETECTOR, a class II device, cleared for Pearce Clinical Laboratories, Inc. on under FDA product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)). FDA records list 3 510(k) clearances for Pearce Clinical Laboratories, Inc., from to . As of , FDA records show no recalls naming K864544.

Clearance record

Decision date
Received
(250 days to decision)
Product code
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Regulation
21 CFR 862.1340
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Pearce Clinical Laboratories, Inc. 805 # San Jacinto, Conroe TX
Third party review
No

Clearances, product code JIL

Trailing 12 months

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

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