Tergitol 7 Agar
FDA 510(k) K853691 · Micro Media Laboratories
510(k) numberK853691
Submission
- Device name
- Tergitol 7 Agar
- Applicant
- Micro Media Laboratories
San Diego, CA, US - Received
- September 4, 1985
- Decision date
- September 17, 1985
- 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
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| 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 |
|---|---|---|
| K853690 | Columbiz Blood AgarJSG · Traditional | 09/17/1985SE |
| K851344 | Oxidative Formentive MediumJSH · Traditional | 04/22/1985SE |
| K851348 | Coba AgarJSJ · Traditional | 04/19/1985SE |
| K851347 | Kanamycin-Vancomycin-Laked Blood AgarJSJ · Traditional | 04/19/1985SE |
| K851346 | Phenylalanine AgarJSH · Traditional | 04/19/1985SE |
| K851345 | Purple BrothJSH · Traditional | 04/19/1985SE |
| K851343 | Brom Cresol Purple StarchJSH · Traditional | 04/19/1985SE |
| K850848 | Brain Heart Infusion AgarJSG · Traditional | 03/20/1985SE |
| K850847 | Thioglycolate Medium W/Vitamin KL & HeminJSG · Traditional | 03/20/1985SE |
| K850846 | Salt BrothJSJ · Traditional | 03/20/1985SE |
Questions and answers
When was Tergitol 7 Agar cleared by the FDA?
Tergitol 7 Agar (K853691) received a 510(k) decision of Substantially Equivalent on September 17, 1985, 13 days after the submission was received.
What is the product code of K853691?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.