Cleared Traditional

OLYMPUS ACID PHOSPHATASE REAGENT

K963640 · Olympus America, Inc. · Chemistry
Feb 1997
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K963640 is an FDA 510(k) clearance for the OLYMPUS ACID PHOSPHATASE REAGENT, a Acid Phosphatase, Naphthyl Phosphate (Class II — Special Controls, product code CKB), submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on February 18, 1997, 159 days after receiving the submission on September 12, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number K963640 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 1996
Decision Date February 18, 1997
Days to Decision 159 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CKB — Acid Phosphatase, Naphthyl Phosphate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1020

Similar Devices — CKB Acid Phosphatase, Naphthyl Phosphate

All 23
DRI-STAT ACID PHOSPHATASE REAGENT
K053612 · Beckman Coulter, Inc. · Apr 2006
ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
K023840 · Bayer Diagnostics Corp. · Jan 2003
ACP
K991010 · Abbott Diagnostics Mfg., Inc. · May 1999
OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER
K981743 · Olympus America, Inc. · Jun 1998
COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)
K974695 · Roche Diagnostic Systems, Inc. · May 1998
IL TEST ACID PHOSPHATASE
K943366 · Instrumentation Laboratory CO · Jan 1996