510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852737Substantially Equivalent

Lactoplate

Mackeen Consultants, Ltd., Bethesda MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852737 is the FDA 510(k) clearance record for LACTOPLATE, a class I device, cleared for Mackeen Consultants, Ltd. on under FDA product code DEG (Lactoferrin, Antigen, Antiserum, Control). FDA records list 2 510(k) clearances for Mackeen Consultants, Ltd., from to . As of , FDA records show no recalls naming K852737.

Clearance record

Decision date
Received
(120 days to decision)
Product code
DEG Lactoferrin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5570
Device class
Class I
Review panel
Immunology
Applicant
Mackeen Consultants, Ltd. 4903 Sangamore Rd., Bethesda MD
Third party review
No

Clearances, product code DEG

Trailing 12 months

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

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