510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K791325Substantially Equivalent

Autopak 12 Digoxin Test Delivery System

Micromedic Systems, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K791325 is the FDA 510(k) clearance record for AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM, a class II device, cleared for Micromedic Systems on under FDA product code DPO (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.). FDA records list 42 510(k) clearances for Micromedic Systems, from to . As of , FDA records show no recalls naming K791325.

Clearance record

Decision date
Received
(35 days to decision)
Product code
DPO Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Micromedic Systems 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DPO

Trailing 12 months

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

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