Eosin Methylene Blue Agar (Emb) - Product #P1309
FDA 510(k) K873225 · Lakewood Biochemical Co., Inc.
510(k) numberK873225
Submission
- Device name
- Eosin Methylene Blue Agar (Emb) - Product #P1309
- Applicant
- Lakewood Biochemical Co., Inc.
Dallas, TX, US - Received
- August 14, 1987
- Decision date
- September 23, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSI – Culture Media, Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
Other 510(k)s with product code JSI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070691 | BBL Chromagar 0157JSI · Traditional | Becton, Dickinson & CO | 11/20/2007SE |
| K974428 | DipstreakJSI · Traditional | Novamed , Ltd. | 07/30/1998SE |
| K891593 | Listeria Selective Enrichment MediumJSI · Traditional | Oxoid U.S.A., Inc. | 06/09/1989SE |
| K890199 | Dentocult Sm-Strip MutansJSI · Traditional | Orion Corp. | 03/02/1989SE |
| K882182 | Salmonella-Shigella (SS) Agar - Product #P3326JSI · Traditional | Lakewood Biochemical Co., Inc. | 06/06/1988SE |
| K881577 | Modified Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881576 | Selenite BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881575 | Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881572 | XL Agar BaseJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881556 | Trichomonas BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K882495 | Thioglycollate Broth W/Vita. K & Hemin - #T3007JSG · Traditional | 07/01/1988SE |
| K882351 | Mueller Hinton Agar Plates P3318/1&2/P3418/P34181JTZ · Traditional | 06/28/1988SE |
| K882463 | Potato Dextrose Agar (Pda) - Product #P3421JSJ · Traditional | 06/22/1988SE |
| K882182 | Salmonella-Shigella (SS) Agar - Product #P3326JSI · Traditional | 06/06/1988SE |
| K880947 | Nutrient Agar Plate, Slant Tube and Broth TubeJSG · Traditional | 04/01/1988SE |
| K880946 | Nutrient Gelatin - Product Number T2860JSF · Traditional | 04/01/1988SE |
| K880945 | Camplyobacter Culture Media Products P3873/T3597JSJ · Traditional | 03/30/1988SE |
| K875136 | Columbia Blood Agar P3308/ Columbia Cna P3750JSG · Traditional | 01/12/1988SE |
| K874538 | Todd-Hewitt Broth (0.5ML)#3099 & (5.OML)#T3516JSG · Traditional | 11/20/1987SE |
| K874537 | Kligler Iron Agar and Triple Sugar Iron AgarJSE · Traditional | 11/20/1987SE |
Questions and answers
When was Eosin Methylene Blue Agar (Emb) - Product #P1309 cleared by the FDA?
Eosin Methylene Blue Agar (Emb) - Product #P1309 (K873225) received a 510(k) decision of Substantially Equivalent on September 23, 1987, 40 days after the submission was received.
What is the product code of K873225?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.