Atlas FDA

ACTIVE RENIN IRMA MODEL NUMBER DSL-25100

FDA 510(k) clearance K981607 · decided 1998-05-27

Clearance details

K-number
K981607
Device name
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
Applicant
Diagnostic Systems Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1998-05-05
Decision date
1998-05-27
Days to decision
22 days
Clearance type
Traditional
Product code
CIB
Device class
2
Regulation number
862.1085
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Webster, TX, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immuno recall (Z-0016-2013)Beckman Coulter Inc.2012-10-05