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510(k) K974572

Device
GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820
Applicant
CHUGAI PHARMACEUTICALS CO., LTD.
510(k) number
K974572
Product code
MDK  
Decision
Substantially Equivalent (SESE)
Decision date
1998-09-24
Date received
1997-12-05
Regulation
866.3740
Classification name
Dna-probe, Reagents, Streptococcal
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GERALD H SCHELL
Address
10210 Genetic Center Dr. San Diego CA US 92121 92121

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MDK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K924715GEN-PROBE DIRECT GROUP A STREPTOCOCUS TESTGen-Probe, Inc.1994-03-11
K915852ACCUPACE GROUP A STREPTOCOCCUS ID TESTGen-Probe, Inc.1992-04-02
K904268ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM.Gen-Probe, Inc.1990-11-13

Legacy Summary#

summary

FDA Review#

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