Of Medium Base
FDA 510(k) K880117 · Hardy Media
510(k) numberK880117
Submission
- Device name
- Of Medium Base
- Applicant
- Hardy Media
Santa Barbara, CA, US - Received
- January 6, 1988
- Decision date
- March 30, 1988
- 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 |
| K873270 | Actinomycete Differential MediaJSH · Traditional | Central Media | 11/04/1987SE |
| K873263 | Maintenance & Carbohydrate Fermentation MediaJSH · Traditional | Central Media | 10/28/1987SE |
| K873411 | Simmons Citrate Medium Slant, Product #T3084JSH · Traditional | Lakewood Biochemical Co., Inc. | 10/06/1987SE |
More from Lakewood Biochemical Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880134 | Middlebrook 7H11 AgarKZI · Traditional | 03/31/1988SE |
| K880133 | Mil MediumJSE · Traditional | 03/31/1988SE |
| K880131 | Lowenstein-Jensen, GruftKZI · Traditional | 03/31/1988SE |
| K880126 | Lauryl Tryptose BrothJSF · Traditional | 03/31/1988SE |
| K880125 | Lowenstein-Jensen, SelectiveJSI · Traditional | 03/31/1988SE |
| K880124 | Lowenstein-Jensen, W/NaclJSJ · Traditional | 03/31/1988SE |
| K880123 | Lowenstein-Jensen SlantJSJ · Traditional | 03/31/1988SE |
| K880122 | Middlebrook 7H9 BrothKZI · Traditional | 03/31/1988SE |
| K880121 | Moellers Decarboxylase, BaseJSH · Traditional | 03/31/1988SE |
| K880120 | Moellers Decarboxylase, LysineJSF · Traditional | 03/31/1988SE |
Questions and answers
When was Of Medium Base cleared by the FDA?
Of Medium Base (K880117) received a 510(k) decision of Substantially Equivalent on March 30, 1988, 84 days after the submission was received.
What is the product code of K880117?
The FDA product code is JSH – Culture Media, Non-Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2320.