Trypticase Soy Agar W/5% Sheep Bld. Cell

FDA 510(k) K802995 · Sacks Farms Biological Products

Substantially Equivalent

510(k) numberK802995

Submission

Device name
Trypticase Soy Agar W/5% Sheep Bld. Cell
Applicant
Sacks Farms Biological Products
Mchenry, IL, US
Received
November 25, 1980
Decision date
December 22, 1980
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

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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
K802994Trypticase Soy Agar W/5% Rabbit Bld. CelJSH · Traditional 12/22/1980SE
K801775Sero Strep KitGTZ · Traditional 10/10/1980SE

Questions and answers

When was Trypticase Soy Agar W/5% Sheep Bld. Cell cleared by the FDA?

Trypticase Soy Agar W/5% Sheep Bld. Cell (K802995) received a 510(k) decision of Substantially Equivalent on December 22, 1980, 27 days after the submission was received.

What is the product code of K802995?

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