FDA 510(k) Premarket Notification K811644: HEKTOEN ENTERIC AGAR

Submission Details & Decision

Normalized public record details for 510(k) notification K811644.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K811644

Applicant / Sponsor

Hardy Media

Device Name

HEKTOEN ENTERIC AGAR

Product Code

JSI

Decision Date

1981-07-02

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Microbiology (MI)

Clearance Type

Traditional

Third Party Flag

Date Received

1981-06-09

Related Establishments / Registrations

BECTON, DICKINSON & CO. Registration: 1111096 View Registration
BECTON, DICKINSON & CO. Registration: 1119779 View Registration
ANALYTICHEM USA, INC. Registration: 1210083 View Registration
REMEL, INC. Registration: 1924669 View Registration
KEY SCIENTIFIC PRODUCTS Registration: 2016672 View Registration
HARDY DIAGNOSTICS Registration: 2022807 View Registration
LIFESIGN L.L.C. Registration: 2249224 View Registration
ANAEROBE SYSTEMS Registration: 2916932 View Registration
Diagnostic Consulting Network, LLC. Registration: 2951280 View Registration
HIMEDIA LABORATORIES PRIVATE LIMITED Registration: 3005182157 View Registration
HIMEDIA LABORATORIES PRIVATE LIMITED Registration: 3005182159 View Registration
BIOMERIEUX SPAIN Registration: 3009307598 View Registration
Hardy Diagnostics Registration: 3009547954 View Registration
S2MEDIA Registration: 3012162776 View Registration
BIOMERIEUX SA Registration: 3013394941 View Registration
K&R TECHNOLOGIES DBA MICROBIOLOGY INTERNATIONAL Registration: 3013823481 View Registration
LEGACY BIOLOGICALS Registration: 3015715780 View Registration
YONG CHANG CO., LTD. Registration: 3017717188 View Registration
HIMEDIA LABORATORIES PRIVATE LIMITED Registration: 3017871324 View Registration
GUANGDONG HUANKAI BIOLOGY SCI.&TECH.CO.,LTD Registration: 3033815621 View Registration
Bio-Rad Service France SAS Registration: 3035708936 View Registration
CREATIVE LIFE SCIENCE CO., LTD. Registration: 3038136284 View Registration
OXOID, LTD. Registration: 8010096 View Registration
BIO-RAD Registration: 8023060 View Registration
SAVYON DIAGNOSTICS LTD. Registration: 8030124 View Registration
AIDIAN OY Registration: 9610102 View Registration
MEDICAL WIRE AND EQUIPMENT CO. LTD. Registration: 9610649 View Registration
SSI Diagnostica A/S Registration: 9611882 View Registration
BIOMERIEUX FRANCE Registration: 9615755 View Registration
CHROMAGAR Registration: 9680687 View Registration

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