510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081013Substantially Equivalent

Microscan Dried Gram-Positive Mic/combo Panels New Antimicrobial Test Cefoxitin Screen

Siemens Healthcare Diagnostics Inc., West Sacramento CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081013 is the FDA 510(k) clearance record for MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN, a class II device, cleared for Siemens Healthcare Diagnostics on under FDA product code LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, from to . As of , FDA records show no recalls naming K081013.

Clearance record

Decision date
Received
(152 days to decision)
Product code
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Siemens Healthcare Diagnostics 2040 Enterprise Blvd., West Sacramento CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LRG

Trailing 12 months

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

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