Cleared Traditional

K850143 - SPORDEX CULTURE MEDIA
(FDA 510(k) Clearance)

K850143 · American Sterilizer Co. · Microbiology device

Mar 1985

Decision

50d

Days

Class 1

Risk

K850143 is an FDA 510(k) clearance for the SPORDEX CULTURE MEDIA. This device is classified as a Culture Media, General Nutrient Broth (Class I - General Controls, product code JSC).

Submitted by American Sterilizer Co. (Erie, US). The FDA issued a Cleared decision on March 5, 1985, 50 days after receiving the submission on January 14, 1985.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2350.

Submission Details

510(k) Number	K850143 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 14, 1985
Decision Date	March 05, 1985
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—