510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882596Substantially Equivalent

Mp Test

Diatech Diagnostica, Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882596 is the FDA 510(k) clearance record for MP TEST, a class I device, cleared for Diatech Diagnostica , Ltd. on under FDA product code LJZ (Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.). FDA records list 3 510(k) clearances for Diatech Diagnostica , Ltd., from to . As of , FDA records show no recalls naming K882596.

Clearance record

Decision date
Received
(362 days to decision)
Product code
LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Regulation
21 CFR 866.3375
Device class
Class I
Review panel
Microbiology
Applicant
Diatech Diagnostica , Ltd. 1120 Vermont Ave., NW, Washington DC
Third party review
No

Clearances, product code LJZ

Trailing 12 months

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

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