Trypticase Soy Broth
FDA 510(k) K864255 · Mds Laboratories, Inc.
510(k) numberK864255
Submission
- Device name
- Trypticase Soy Broth
- Applicant
- Mds Laboratories, Inc.
L5j 2m4, CA - Received
- October 28, 1986
- Decision date
- March 31, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSG – Culture Media, Non-Selective And Non-Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2300
- Specialty
- Microbiology
Other 510(k)s with product code JSG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882495 | Thioglycollate Broth W/Vita. K & Hemin - #T3007JSG · Traditional | Lakewood Biochemical Co., Inc. | 07/01/1988SE |
| K881564 | Tryptose Blood Agar Base W/Yeast ExtractJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881563 | Tryptose Phosphate BrothJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881562 | Tryptose Blood Agar BaseJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881558 | Tryptose AgarJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881557 | TryptoneJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881554 | Skim Milk DehydratedJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881550 | Of Basal MediumJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881548 | MPH AgarJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881546 | Malt Extract AgarJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K864256 | Tryptone Water (1%)JSF · Traditional | 03/31/1987SE |
| K864254 | Thioglycollate BrothJSG · Traditional | 03/31/1987SE |
| K864253 | Thayer Martin AgarJTY · Traditional | 03/31/1987SE |
| K864252 | Thayer-Martin JembecJTY · Traditional | 03/31/1987SE |
| K864251 | Selenite F. BrothJSJ · Traditional | 03/31/1987SE |
| K864250 | Sabouraud Dextrose AgarJSJ · Traditional | 03/31/1987SE |
| K864249 | Normal Saline SterileLIB · Traditional | 03/31/1987SE |
| K864248 | Mueller Hinton Agar - SupplementedJTZ · Traditional | 03/31/1987SE |
| K864247 | Mueller Hinton Agar with 5% Sheep BloodJTZ · Traditional | 03/31/1987SE |
| K864246 | Mueller Hinton Agar LargeJTZ · Traditional | 03/31/1987SE |
Questions and answers
When was Trypticase Soy Broth cleared by the FDA?
Trypticase Soy Broth (K864255) received a 510(k) decision of Substantially Equivalent on March 31, 1987, 154 days after the submission was received.
What is the product code of K864255?
The FDA product code is JSG – Culture Media, Non-Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2300.