NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)

FDA 510(k) clearance K011128 · decided 2001-09-06

Clearance details

K-number: K011128
Device name: NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
Applicant: Nichols Institute Diagnostics
Decision: Substantially Equivalent
Date received: 2001-04-13
Decision date: 2001-09-06
Days to decision: 146 days
Clearance type: Traditional
Product code: CIB
Device class: 2
Regulation number: 862.1085
Medical specialty: Clinical Chemistry
Advisory committee: Clinical Chemistry
Location: San Juan Capistrano, CA, US
Third-party review: No
Expedited review: No

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Devices cleared under the same product code - the starting set for predicate research.

Record	Firm	Date
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS (K123763)	Immunodiagnostic Systems , Ltd.	2013-12-24
LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT (K121944)	DiaSorin, Inc.	2013-01-01
CISBIO RENIN RIA TEST (K062120)	Cis Bio International	2007-03-30
ACTIVE RENIN IRMA (K061758)	Diagnostic Systems Laboratories, Inc.	2006-07-28
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 (K981607)	Diagnostic Systems Laboratories, Inc.	1998-05-27
BUHLMANN ANGIOSTENSIN II RIA (K954299)	Buhlmann Laboratories AG	1995-10-19
AI-PHOTODIAGNOSTIC (K940004)	Pharmarceutical Discovery Corp.	1995-08-04
ACTIVE RENIN IMMUNORADIOMETRIC ASSAY (K925998)	Nichols Institute Diagnostics	1993-01-06
RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI (K850054)	E.I. Dupont DE Nemours & Co., Inc.	1985-03-29
RENIN RADIOIMMUNOASSAY TEST KIT (K842966)	Serono Diagnostics, Inc.	1984-10-11
ANGIOTENSIN CONVERTING ENZYME (K833777)	Immuno-Diagnostic Laboratories	1984-01-30
RENAK (K831694)	Hoffmann-La Roche, Inc.	1983-07-19

No recalls on record reference this clearance.