Thioglycolate Medium W/Vitamin KL & Hemin

FDA 510(k) K850847 · Micro Media Laboratories

Substantially Equivalent

510(k) numberK850847

Submission

Device name
Thioglycolate Medium W/Vitamin KL & Hemin
Applicant
Micro Media Laboratories
San Diego, CA, US
Received
March 1, 1985
Decision date
March 20, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JSG – Culture Media, Non-Selective And Non-Differential
Device class
Class I (low risk)
Regulation
21 CFR 866.2300
Specialty
Microbiology

Other 510(k)s with product code JSG

510(k)DeviceApplicantDecision
K882495Thioglycollate Broth W/Vita. K & Hemin - #T3007JSG · Traditional Lakewood Biochemical Co., Inc.07/01/1988SE
K881564Tryptose Blood Agar Base W/Yeast ExtractJSG · Traditional Acumedia Manufacturers, Inc.04/18/1988SE
K881563Tryptose Phosphate BrothJSG · Traditional Acumedia Manufacturers, Inc.04/18/1988SE
K881562Tryptose Blood Agar BaseJSG · Traditional Acumedia Manufacturers, Inc.04/18/1988SE
K881558Tryptose AgarJSG · Traditional Acumedia Manufacturers, Inc.04/18/1988SE
K881557TryptoneJSG · Traditional Acumedia Manufacturers, Inc.04/18/1988SE
K881554Skim Milk DehydratedJSG · Traditional Acumedia Manufacturers, Inc.04/18/1988SE
K881550Of Basal MediumJSG · Traditional Acumedia Manufacturers, Inc.04/18/1988SE
K881548MPH AgarJSG · Traditional Acumedia Manufacturers, Inc.04/18/1988SE
K881546Malt Extract AgarJSG · Traditional Acumedia Manufacturers, Inc.04/18/1988SE

More from Acumedia Manufacturers, Inc.

510(k)DeviceDecision
K853691Tergitol 7 AgarJSI · Traditional 09/17/1985SE
K853690Columbiz Blood AgarJSG · Traditional 09/17/1985SE
K851344Oxidative Formentive MediumJSH · Traditional 04/22/1985SE
K851348Coba AgarJSJ · Traditional 04/19/1985SE
K851347Kanamycin-Vancomycin-Laked Blood AgarJSJ · Traditional 04/19/1985SE
K851346Phenylalanine AgarJSH · Traditional 04/19/1985SE
K851345Purple BrothJSH · Traditional 04/19/1985SE
K851343Brom Cresol Purple StarchJSH · Traditional 04/19/1985SE
K850848Brain Heart Infusion AgarJSG · Traditional 03/20/1985SE
K850846Salt BrothJSJ · Traditional 03/20/1985SE

Questions and answers

When was Thioglycolate Medium W/Vitamin KL & Hemin cleared by the FDA?

Thioglycolate Medium W/Vitamin KL & Hemin (K850847) received a 510(k) decision of Substantially Equivalent on March 20, 1985, 19 days after the submission was received.

What is the product code of K850847?

The FDA product code is JSG – Culture Media, Non-Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2300.