510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K872082Substantially Equivalent

Respiratory Syncytial Virus Control Slide

Medical Diagnostic Technologies, Inc., Augusta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872082 is the FDA 510(k) clearance record for RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE, a class I device, cleared for Medical Diagnostic Technologies, Inc. on under FDA product code LKT (Respiratory Syncytial Virus, Antigen, Antibody, Ifa). FDA records list 57 510(k) clearances for Medical Diagnostic Technologies, Inc., from to . As of , FDA records show no recalls naming K872082.

Clearance record

Decision date
Received
(63 days to decision)
Product code
LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Regulation
21 CFR 866.3480
Device class
Class I
Review panel
Microbiology
Applicant
Medical Diagnostic Technologies, Inc. 3351 Wrightsboro Rd., Augusta GA
Third party review
No

Clearances, product code LKT

Trailing 12 months

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

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