510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K862368Substantially Equivalent

Amplified Elisa Ige Kit

Allertec, Inc., San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862368 is the FDA 510(k) clearance record for AMPLIFIED ELISA IGE KIT, a class II device, cleared for Allertec, Inc. on under FDA product code DGC (Ige, Antigen, Antiserum, Control). FDA records list 2 510(k) clearances for Allertec, Inc., from to . As of , FDA records show no recalls naming K862368.

Clearance record

Decision date
Received
(9 days to decision)
Product code
DGC Ige, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Allertec, Inc. 490 Post Stree, Suite 1230, San Francisco CA
Third party review
No

Clearances, product code DGC

Trailing 12 months

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

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