Simmons Citrate Agar

FDA 510(k) K851595 · Preferred Micro-Media

Substantially Equivalent

510(k) numberK851595

Submission

Device name
Simmons Citrate Agar
Applicant
Preferred Micro-Media
Toledo, OH, US
Received
April 16, 1985
Decision date
May 13, 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
K851594SF BrothJSI · Traditional 05/14/1985SE
K851597Triple Sugar Iron AgarJSH · Traditional 05/13/1985SE
K851596Sim MediumJSH · Traditional 05/13/1985SE
K851593Selective Streptococcus AgarJSJ · Traditional 05/13/1985SE
K851592Sabouraud Dextrose AgarJSJ · Traditional 05/13/1985SE
K851591Phenylethyl Alcohol Agar W/5%SHEEP BloodJSJ · Traditional 05/13/1985SE
K851598Thioglycollate Without IndicatorJSG · Traditional 05/10/1985SE
K851576Biggy Agar Nickersons MediumJSH · Traditional 05/09/1985SE
K851603Xylose Lysine Desoxycholate AgarJSI · Traditional 05/08/1985SE
K851602Urea AgarJSH · Traditional 05/08/1985SE

Questions and answers

When was Simmons Citrate Agar cleared by the FDA?

Simmons Citrate Agar (K851595) received a 510(k) decision of Substantially Equivalent on May 13, 1985, 27 days after the submission was received.

What is the product code of K851595?

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