510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K092649Substantially Equivalent

Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160, 04842472-190

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

K092649 is the FDA 510(k) clearance record for ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code NBC (Test, Natriuretic Peptide). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming K092649.

Clearance record

Decision date
Received
(160 days to decision)
Product code
NBC Test, Natriuretic Peptide
Regulation
21 CFR 862.1117
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NBC

Trailing 12 months
4 clearances under product code NBC in the twelve months to November 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NBC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20261
November 20260