510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982382Substantially Equivalent

Cobas Integra Reagent Cassettes

Roche Diagnostic Systems, Inc., Somerville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982382 is the FDA 510(k) clearance record for COBAS INTEGRA REAGENT CASSETTES, a class II device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code CFN (Method, Nephelometric, Immunoglobulins (G, A, M)). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show one recall naming K982382.

Clearance record

Decision date
Received
(82 days to decision)
Product code
CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Roche Diagnostic Systems, Inc. Branchburg Township, Somerville NJ
510(k) summary
Summary
Third party review
No

Clearances, product code CFN

Trailing 12 months

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

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