510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823900Substantially Equivalent

Glucose-6-Phosphate Dehydrogenase

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

K823900 is the FDA 510(k) clearance record for GLUCOSE-6-PHOSPHATE DEHYDROGENASE, a class II device, cleared for Alladin Diagnostic, Inc. on under FDA product code KQE (Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase). FDA records list 2 510(k) clearances for Alladin Diagnostic, Inc., from to . As of , FDA records show no recalls naming K823900.

Clearance record

Decision date
Received
(39 days to decision)
Product code
KQE Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase
Regulation
21 CFR 864.7360
Device class
Class II
Review panel
Hematology
Applicant
Alladin Diagnostic, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KQE

Trailing 12 months

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

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