Ak Agar 2

FDA 510(k) K833207 · Acumedia Manufacturers, Inc.

Substantially Equivalent

510(k) numberK833207

Submission

Device name
Ak Agar 2
Applicant
Acumedia Manufacturers, Inc.
Mchenry, IL, US
Received
September 19, 1983
Decision date
October 27, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LKA – Culture Media, Antimicrobial Susceptibility Test
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1700
Specialty
Microbiology

Other 510(k)s with product code LKA

510(k)DeviceApplicantDecision
K872688Iafp Mueller Hinton Agar W/5% Sheep BloodLKA · Traditional I.A.F. Production, Inc.08/11/1987SE
K872687Iafp Mueller Hinton Agar W/Hemo. W/Cva EnrichmentLKA · Traditional I.A.F. Production, Inc.08/11/1987SE
K872686Iafp Mueller Hinton AgarLKA · Traditional I.A.F. Production, Inc.08/11/1987SE
K833218Yeast Beef Agar-Antibiotic MED.4LKA · Traditional Acumedia Manufacturers, Inc.10/27/1983SE

More from Acumedia Manufacturers, Inc.

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 Ak Agar 2 cleared by the FDA?

Ak Agar 2 (K833207) received a 510(k) decision of Substantially Equivalent on October 27, 1983, 38 days after the submission was received.

What is the product code of K833207?

The FDA product code is LKA – Culture Media, Antimicrobial Susceptibility Test, a Class II (moderate risk) device regulated under 21 CFR 866.1700.