Kliger's Iron Agar, Sim Media, MRVP Medium, Bile E

FDA 510(k) K850721 · Rapid City Regional Hospital, Inc.

Substantially Equivalent

510(k) numberK850721

Submission

Device name
Kliger's Iron Agar, Sim Media, MRVP Medium, Bile E
Applicant
Rapid City Regional Hospital, Inc.
Rapid City, SD, US
Received
February 22, 1985
Decision date
March 22, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JSH – Culture Media, Non-Selective And Differential
Device class
Class I (low risk)
Regulation
21 CFR 866.2320
Specialty
Microbiology

Other 510(k)s with product code JSH

510(k)DeviceApplicantDecision
K881560Urea BrothJSH · Traditional Acumedia Manufacturers, Inc.04/18/1988SE
K881559Urea Agar BaseJSH · Traditional Acumedia Manufacturers, Inc.04/18/1988SE
K881553Russell Double Sugar AgarJSH · Traditional Acumedia Manufacturers, Inc.04/18/1988SE
K881551Phenol Red Broth BaseJSH · Traditional Acumedia Manufacturers, Inc.04/18/1988SE
K881540Flo AgarJSH · Traditional Acumedia Manufacturers, Inc.04/18/1988SE
K881486Dnase Test AgarJSH · Traditional Acumedia Manufacturers, Inc.04/18/1988SE
K880121Moellers Decarboxylase, BaseJSH · Traditional Hardy Media03/31/1988SE
K880117Of Medium BaseJSH · Traditional Hardy Media03/30/1988SE
K873270Actinomycete Differential MediaJSH · Traditional Central Media11/04/1987SE
K873263Maintenance & Carbohydrate Fermentation MediaJSH · Traditional Central Media10/28/1987SE

More from Central Media

510(k)DeviceDecision
K850724Culture Media Nonselective & NondifferentialKZI · Traditional 03/25/1985SE
K850723Sabouraud's Dextrose Agar, Bordet Gengou Agar, MycJSI · Traditional 03/22/1985SE
K850722Martin Lewis AgarJTY · Traditional 03/22/1985SE
K850720Eosin Methylene Blue Agar, SS Agar, XLD Agar 6.5%JSI · Traditional 03/22/1985SE
K850719Dnase Test Media, Christensen's Urea AgarJSH · Traditional 03/22/1985SE
K850717Amies Transport MediaJSM · Traditional 03/22/1985SE
K850716Selenite F BrothJSJ · Traditional 03/22/1985SE
K850715Mueller Hinton AgarJTZ · Traditional 03/22/1985SE
K850718Corn Meal AgarJSH · Traditional 03/20/1985SE

Questions and answers

When was Kliger's Iron Agar, Sim Media, MRVP Medium, Bile E cleared by the FDA?

Kliger's Iron Agar, Sim Media, MRVP Medium, Bile E (K850721) received a 510(k) decision of Substantially Equivalent on March 22, 1985, 28 days after the submission was received.

What is the product code of K850721?

The FDA product code is JSH – Culture Media, Non-Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2320.