510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151578Substantially Equivalent

Carbamazepine Gen 4

Roche Diagnostics Operations (Rdo), Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151578 is the FDA 510(k) clearance record for Carbamazepine Gen 4, a class II device, cleared for Roche Diagnostics Operations (Rdo) on under FDA product code KLT (Enzyme Immunoassay, Carbamazepine). FDA records list 14 510(k) clearances for Roche Diagnostics Operations (Rdo), from to . As of , FDA records show no recalls naming K151578.

Clearance record

Decision date
Received
(133 days to decision)
Product code
KLT Enzyme Immunoassay, Carbamazepine
Regulation
21 CFR 862.3645
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Roche Diagnostics Operations (Rdo) 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KLT

Trailing 12 months

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

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