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510(k) K780972

Device
Quickrate Reaction Rate Analyzer
Applicant
OLYMPUS CORP.
510(k) number
K780972
Product code
JJI
Decision
Substantially Equivalent (SESE)
Decision date
1978-08-14
Date received
1978-06-12
Regulation
862.2500
Classification name
Analyzer, Enzyme, For Clinical Use
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JJI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972024CODA AUTOMATED EIA ANALYZERBio-Rad1997-07-30
K944731ABBOTT IMX 2 ANALYZERAbbott Laboratories1994-12-19
K931970ABBOTT IMX2 ANALYERAbbott Laboratories1993-06-16
K930898RADIAS AUTOMATED IMMUNOASSAY SYSTEMBio-Rad1993-04-21
K790073ANALYZER, IMPACT 100Gilford Instrument Laboratories, Inc.1979-02-22
K771591MINISTAT-S CHEMISTRY ANALYZERBiokinetix Corp.1977-09-20
K770401LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASEBd Becton Dickinson Vacutainer Systems Preanalytic1977-04-26