510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K072901Substantially Equivalent

Amdl-Elisa Dr-70 (Fdp) Immunoassay, Model Dr2101

Amdl, Inc., Tustin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072901 is the FDA 510(k) clearance record for AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101, a class II device, cleared for Amdl, Inc. on under FDA product code NTY (System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer). FDA's definition for product code NTY reads: "MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES". FDA records list 2 510(k) clearances for Amdl, Inc., from to . As of , FDA records show no recalls naming K072901.

Clearance record

Decision date
Received
(264 days to decision)
Product code
NTY System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Amdl, Inc. 2492 Walnut Ave. Suite 100, Tustin CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NTY

Trailing 12 months

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

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