Atlas FDA

ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN

FDA 510(k) clearance K083260 · decided 2009-10-16

Clearance details

K-number
K083260
Device name
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2008-11-05
Decision date
2009-10-16
Days to decision
345 days
Clearance type
Traditional
Product code
DDR
Device class
2
Regulation number
866.5680
Medical specialty
Immunology
Advisory committee
Immunology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S007)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S006)Roche Diagnostics2024-10-03
Elecsys Anti-HBs / Elecsys HBs II (P190034/S009)Roche Diagnostics2024-10-03
Elecsys Anti-HBs II (P190034/S008)Roche Diagnostics2024-08-29
Elecsys Anti-HBe (P190005/S005)Roche Diagnostics2024-08-29
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007)Roche Diagnostics2024-07-23
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005)Roche Diagnostics2024-05-01