Extract Broth

FDA 510(k) K832570 · Acumedia Manufacturers, Inc.

Substantially Equivalent

510(k) numberK832570

Submission

Device name
Extract Broth
Applicant
Acumedia Manufacturers, Inc.
Mchenry, IL, US
Received
August 2, 1983
Decision date
September 12, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JSC – Culture Media, General Nutrient Broth
Device class
Class I (low risk)
Regulation
21 CFR 866.2350
Specialty
Microbiology

Other 510(k)s with product code JSC

510(k)DeviceApplicantDecision
K850143Spordex Culture MediaJSC · Traditional American Sterilizer Co.03/05/1985SE
K842852Brain Heart Infusion BrothJSC · Traditional Anarobe Systems08/03/1984SE
K842849Trypticase Soy BrothJSC · Traditional Anarobe Systems08/03/1984SE
K841221Brain Heart Infusion BrothJSC · Traditional Anaerobe Systems04/04/1984SE
K841219Shopped Meat CarbohydrateJSC · Traditional Anaerobe Systems04/04/1984SE
K833300Sabouraud Bhi AgarJSC · Traditional Acumedia Manufacturers, Inc.11/07/1983SE
K832620Tryptic Soy Broth MediaJSC · Traditional Carroll Biological Corp.09/12/1983SE
K832619Thioglycollate MediumJSC · Traditional Carroll Biological Corp.09/12/1983SE
K832569Infusion BrothJSC · Traditional Acumedia Manufacturers, Inc.09/12/1983SE
K830437CHSJSC · Traditional Dms Laboratories03/17/1983SE

More from Dms Laboratories

510(k)DeviceDecision
K881579Amies Transport Medium W/O CharcoalJSN · Traditional 04/18/1988SE
K881578StreptoselJSJ · Traditional 04/18/1988SE
K881577Modified Selective Streptococcus AgarJSI · Traditional 04/18/1988SE
K881576Selenite BrothJSI · Traditional 04/18/1988SE
K881575Selective Streptococcus AgarJSI · Traditional 04/18/1988SE
K881574W-L Differential MediumJSJ · Traditional 04/18/1988SE
K881573Phytone Yeast Extract AgarJSJ · Traditional 04/18/1988SE
K881572XL Agar BaseJSI · Traditional 04/18/1988SE
K881571Ym BrothJSJ · Traditional 04/18/1988SE
K881570Sabouraud Maltose AgarJSJ · Traditional 04/18/1988SE

Questions and answers

When was Extract Broth cleared by the FDA?

Extract Broth (K832570) received a 510(k) decision of Substantially Equivalent on September 12, 1983, 41 days after the submission was received.

What is the product code of K832570?

The FDA product code is JSC – Culture Media, General Nutrient Broth, a Class I (low risk) device regulated under 21 CFR 866.2350.