FDA 510(k) Premarket Notification K834001: KLIGLER IRON AGAR

Submission Details & Decision

Normalized public record details for 510(k) notification K834001.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K834001

Applicant / Sponsor

Micro Media Laboratories

Device Name

KLIGLER IRON AGAR

Product Code

JSE

Decision Date

1983-12-22

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Microbiology (MI)

Clearance Type

Traditional

Third Party Flag

Date Received

1983-11-21

Related Establishments / Registrations

ANALYTICHEM USA, INC. Registration: 1210083 View Registration
REMEL, INC. Registration: 1924669 View Registration
HARDY DIAGNOSTICS Registration: 2022807 View Registration
REMEL EUROPE LTD Registration: 3003750284 View Registration
HIMEDIA LABORATORIES PRIVATE LIMITED Registration: 3005182157 View Registration
HIMEDIA LABORATORIES PRIVATE LIMITED Registration: 3005182159 View Registration
Hardy Diagnostics Registration: 3009547954 View Registration
LEGACY BIOLOGICALS Registration: 3015715780 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.