Dentocult-Sm Culture-Paddle
FDA 510(k) K872301 · Orion Corp.
510(k) numberK872301
Submission
- Device name
- Dentocult-Sm Culture-Paddle
- Applicant
- Orion Corp.
20101 Turku, FI - Received
- June 15, 1987
- Decision date
- September 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
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| 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 |
|---|---|---|
| K912391 | Rubalex, ModificationLQN · Traditional | 05/04/1992SE |
| K901637 | Resubmitted Modified RubalexLQN · Traditional | 04/26/1990SE |
| K884650 | Resubmitted ScanoraIZF · Traditional | 03/16/1989SE |
| K890199 | Dentocult Sm-Strip MutansJSI · Traditional | 03/02/1989SE |
| K881506 | Mamex DC Mag MG12IZH · Traditional | 06/10/1988SE |
| K881505 | Mamex DC MG11IZH · Traditional | 06/10/1988SE |
| K874040 | Mamex DC S SL10/MG14IZH · Traditional | 11/23/1987SE |
| K872744 | Modified Chlamyset AntigenLJP · Traditional | 09/22/1987SE |
| K864457 | Chlamyset Antibody EiaLJC · Traditional | 09/11/1987SE |
| K872058 | Oricult-N Culture-PaddleJSI · Traditional | 06/10/1987SE |
Questions and answers
When was Dentocult-Sm Culture-Paddle cleared by the FDA?
Dentocult-Sm Culture-Paddle (K872301) received a 510(k) decision of Substantially Equivalent on September 11, 1987, 88 days after the submission was received.
What is the product code of K872301?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.