510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010984Substantially Equivalent

Emit 2000 Gentamicin Plus Assay

Syva Co., Dade Behring, Inc., San Jose CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K010984 is the FDA 510(k) clearance record for EMIT 2000 GENTAMICIN PLUS ASSAY, a class II device, cleared for Syva Co., Dade Behring, Inc. on under FDA product code LCD (Enzyme Immunoassay, Gentamicin). FDA records list 19 510(k) clearances for Syva Co., Dade Behring, Inc., from to . As of , FDA records show no recalls naming K010984.

Clearance record

Decision date
Received
(18 days to decision)
Product code
LCD Enzyme Immunoassay, Gentamicin
Regulation
21 CFR 862.3450
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Syva Co., Dade Behring, Inc. 3403 Yerba Buena Rd., San Jose CA
510(k) summary
Summary
Third party review
No

Clearances, product code LCD

Trailing 12 months

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

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