Chocolate Agar

FDA 510(k) K841586 · Microline Scientific

Substantially Equivalent

510(k) numberK841586

Submission

Device name
Chocolate Agar
Applicant
Microline Scientific
Mchenry, IL, US
Received
April 17, 1984
Decision date
May 31, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KZI – Culture Media, Enriched
Device class
Class I (low risk)
Regulation
21 CFR 866.2330
Specialty
Microbiology

Other 510(k)s with product code KZI

510(k)DeviceApplicantDecision
K884208Listeria Selective Medium (Oxford Formulation)KZI · Traditional Oxoid U.S.A., Inc.10/25/1988SE
K881995Diamond's Medium ModifiedKZI · Traditional Remel Co.06/02/1988SE
K880134Middlebrook 7H11 AgarKZI · Traditional Hardy Media03/31/1988SE
K880131Lowenstein-Jensen, GruftKZI · Traditional Hardy Media03/31/1988SE
K880122Middlebrook 7H9 BrothKZI · Traditional Hardy Media03/31/1988SE
K880138Wallenstein Medium SlantKZI · Traditional Hardy Media03/30/1988SE
K880109Cystine Tryptic Medium BaseKZI · Traditional Hardy Media03/30/1988SE
K880127Potato Dextrose AgarKZI · Traditional Hardy Media03/07/1988SE
K874179Biotis (TM) Sabhi (Double Pour)KZI · Traditional Otisville Biopharm, Inc.01/28/1988SE
K874177Biotis (TM) BcyeKZI · Traditional Otisville Biopharm, Inc.12/04/1987SE

More from Otisville Biopharm, Inc.

510(k)DeviceDecision
K841845Selective Culture Med. Columbia CnaJSJ · Traditional 05/31/1984SE
K841844Differential Culture Medium-Biggy AgarJSI · Traditional 05/31/1984SE
K841843Differential Culture Med. Levine EmbJSH · Traditional 05/31/1984SE
K841842Differential Culture Med. Macconkey AgarJSI · Traditional 05/31/1984SE
K841841Differential Culture Med. Mannitol SaltJSI · Traditional 05/25/1984SE
K841840Selective Culture Med. Phenylethyl AlcoJSJ · Traditional 05/25/1984SE
K841839Selective Culture Med. Selective StrepJSJ · Traditional 05/25/1984SE
K841838Enriched Culture Med. Tryptic Soy AgarKZI · Traditional 05/21/1984SE
K841837Enriched Culture Med. Fluid THIOGLYC0KZI · Traditional 05/21/1984SE
K841836Selective Culture Med. TrichomonasJSD · Traditional 05/14/1984SE

Questions and answers

When was Chocolate Agar cleared by the FDA?

Chocolate Agar (K841586) received a 510(k) decision of Substantially Equivalent on May 31, 1984, 44 days after the submission was received.

What is the product code of K841586?

The FDA product code is KZI – Culture Media, Enriched, a Class I (low risk) device regulated under 21 CFR 866.2330.