Sorbitol Macconkey (Smac) Agar, Dri & Pre-Form
FDA 510(k) K871855 · Gibco Laboratories Life Technologies, Inc.
510(k) numberK871855
Submission
- Device name
- Sorbitol Macconkey (Smac) Agar, Dri & Pre-Form
- Applicant
- Gibco Laboratories Life Technologies, Inc.
Madison, WI, US - Received
- May 13, 1987
- Decision date
- May 26, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSH – Culture Media, Non-Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Specialty
- Microbiology
Other 510(k)s with product code JSH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881560 | Urea BrothJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881559 | Urea Agar BaseJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881553 | Russell Double Sugar AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881551 | Phenol Red Broth BaseJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881540 | Flo AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881486 | Dnase Test AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K880121 | Moellers Decarboxylase, BaseJSH · Traditional | Hardy Media | 03/31/1988SE |
| K880117 | Of Medium BaseJSH · Traditional | Hardy Media | 03/30/1988SE |
| K873270 | Actinomycete Differential MediaJSH · Traditional | Central Media | 11/04/1987SE |
| K873263 | Maintenance & Carbohydrate Fermentation MediaJSH · Traditional | Central Media | 10/28/1987SE |
More from Central Media
| 510(k) | Device | Decision |
|---|---|---|
| K871541 | Martin-Lewis Agar W/Reduced Vancomycin C0226JTY · Traditional | 04/29/1987SE |
| K870134 | Mcbride Listeria Agar W/Cycloheximide, Dri & PreJSJ · Traditional | 02/04/1987SE |
| K864755 | Pseudomonas Cepacia Selective Agar, Dri & Pre-FormJSJ · Traditional | 01/05/1987SE |
| K864014 | Lombard Dowell Agar BaseKZI · Traditional | 10/29/1986SE |
| K863821 | Mueller Hinton Agar W/4%NACL and OxacillinJTZ · Traditional | 10/09/1986SE |
| K863820 | Dri-Form: Gbna Listeria Medium No. M22300JSJ · Traditional | 10/08/1986SE |
| K863289 | CDC Anaerobic Agar W/Sheep Blood, Kana-&VancomycinJSJ · Traditional | 09/03/1986SE |
| K862425 | Macconkey Agar W/Mug, Dri-Form and Pre-FormJSI · Traditional | 07/02/1986SE |
| K861058 | Sensititre Auto Id Plate, AP70JTO · Traditional | 05/20/1986SE |
| K861734 | Regan-Lowe AgarJSJ · Traditional | 05/16/1986SE |
Questions and answers
When was Sorbitol Macconkey (Smac) Agar, Dri & Pre-Form cleared by the FDA?
Sorbitol Macconkey (Smac) Agar, Dri & Pre-Form (K871855) received a 510(k) decision of Substantially Equivalent on May 26, 1987, 13 days after the submission was received.
What is the product code of K871855?
The FDA product code is JSH – Culture Media, Non-Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2320.