510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853607Substantially Equivalent

Allerg-E Ige Enzyme Immunoassay Kit

Dexall Biomedical Labs, Inc., Gaithersburg MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853607 is the FDA 510(k) clearance record for ALLERG-E IGE ENZYME IMMUNOASSAY KIT, a class II device, cleared for Dexall Biomedical Labs, Inc. on under FDA product code DGO (Ige, Peroxidase, Antigen, Antiserum, Control). FDA records list 4 510(k) clearances for Dexall Biomedical Labs, Inc., from to . As of , FDA records show no recalls naming K853607.

Clearance record

Decision date
Received
(71 days to decision)
Product code
DGO Ige, Peroxidase, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Dexall Biomedical Labs, Inc. 145-4 Professional Dr., Gaithersburg MD
Third party review
No

Clearances, product code DGO

Trailing 12 months

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

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