510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844287Substantially Equivalent

Adpifa Test for Antibodies to Toxoplasma Gondii

Apple Diagnostic Products, Pipersille PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844287 is the FDA 510(k) clearance record for ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII, a class II device, cleared for Apple Diagnostic Products on under FDA product code GLZ (Antigens, If, Toxoplasma Gondii). FDA records list 7 510(k) clearances for Apple Diagnostic Products, from to . As of , FDA records show no recalls naming K844287.

Clearance record

Decision date
Received
(63 days to decision)
Product code
GLZ Antigens, If, Toxoplasma Gondii
Regulation
21 CFR 866.3780
Device class
Class II
Review panel
Microbiology
Applicant
Apple Diagnostic Products P.O. Box 216, Pipersille PA
Third party review
No

Clearances, product code GLZ

Trailing 12 months

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

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