FDA.report

510(k) K962843

Device
MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
Applicant
STARPLEX SCIENTIFIC, INC.
510(k) number
K962843
Product code
JSM  
Decision
Substantially Equivalent (SESE)
Decision date
1996-09-18
Date received
1996-07-22
Regulation
866.2390
Classification name
Culture Media, Non-propagating Transport
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
MEHDI KARAMCHI
Address
50-B Steinway Blvd. Etobicoke, Ontario CA M9W 6Y3 M9W 6Y3

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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