Iafp S.S. Agar
FDA 510(k) K872682 · I.A.F. Production, Inc.
510(k) numberK872682
Submission
- Device name
- Iafp S.S. Agar
- Applicant
- I.A.F. Production, Inc.
Laval, Que. H7n-423, CA - Received
- July 7, 1987
- Decision date
- August 11, 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 |
|---|---|---|
| K872690 | Iafp V. Agar SelectiveJSJ · Traditional | 09/14/1987SE |
| K872692 | Iafp P.E.A. Agar W/5% Sheep BloodJSJ · Traditional | 08/11/1987SE |
| K872691 | Iafp Urea Agar SlantJSF · Traditional | 08/11/1987SE |
| K872689 | Iafp Sabouraud Dextrose AgarJSJ · Traditional | 08/11/1987SE |
| K872688 | Iafp Mueller Hinton Agar W/5% Sheep BloodLKA · Traditional | 08/11/1987SE |
| K872687 | Iafp Mueller Hinton Agar W/Hemo. W/Cva EnrichmentLKA · Traditional | 08/11/1987SE |
| K872686 | Iafp Mueller Hinton AgarLKA · Traditional | 08/11/1987SE |
| K872685 | Iafp Lowenstein Jensen SlantKZI · Traditional | 08/11/1987SE |
| K872684 | Iafp Campylobacter BlaserJSJ · Traditional | 08/11/1987SE |
| K872683 | Iafp Bile Esculin AgarJSI · Traditional | 08/11/1987SE |
Questions and answers
When was Iafp S.S. Agar cleared by the FDA?
Iafp S.S. Agar (K872682) received a 510(k) decision of Substantially Equivalent on August 11, 1987, 35 days after the submission was received.
What is the product code of K872682?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.