Cleared Traditional

TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY

K961573 · Hybritech, Inc. · Chemistry
Aug 1996
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K961573 is an FDA 510(k) clearance for the TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY, a Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (Class II — Special Controls, product code CIN), submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on August 19, 1996, 118 days after receiving the submission on April 23, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K961573 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 1996
Decision Date August 19, 1996
Days to Decision 118 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIN — Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

Similar Devices — CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

All 25
Access Ostase
K232904 · Beckman Coulter · Apr 2024
IDS-iSYS Ostase BAP
K200475 · Immunodiagnostic Systems , Ltd. · Sep 2020
ORION DIAGNOSTICA UNIQ PINP RIA
K043125 · Orion Diagnostica, OY · May 2005
SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346
K020625 · Helena Laboratories · May 2002
HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)
K011113 · Sebia · Jun 2001
ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
K994278 · Beckman Coulter, Inc. · Mar 2000