ACTIVE RENIN IRMA MODEL NUMBER DSL-25100— 510(k) K981607
Substantially EquivalentDiagnostic Systems Laboratories, Inc.
FDA 510(k) clearance K981607 for ACTIVE RENIN IRMA MODEL NUMBER DSL-25100, Substantially Equivalent on 1998-05-27. Applicant: Diagnostic Systems Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Systems Laboratories, Inc.
- Product code
- Code CIB
- Device class
- Class 2
- Regulation
- 21 CFR 862.1085
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Webster, TX, US
Recent devices under product code CIB
view all- K123763 — IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS
- K121944 — LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
- K062120 — CISBIO RENIN RIA TEST
- K061758 — ACTIVE RENIN IRMA
- K011128 — NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
More clearances from Diagnostic Systems Laboratories, Inc.
view allRecalls naming K981607
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981607.
Data sourced from openFDA. This site is unofficial and independent of the FDA.