Tryptone Water (1%)
FDA 510(k) K864256 · Mds Laboratories, Inc.
510(k) numberK864256
Submission
- Device name
- Tryptone Water (1%)
- 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
- JSF – Culture Media, Single Biochemical Test
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Specialty
- Microbiology
Other 510(k)s with product code JSF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K880946 | Nutrient Gelatin - Product Number T2860JSF · Traditional | Lakewood Biochemical Co., Inc. | 04/01/1988SE |
| K880126 | Lauryl Tryptose BrothJSF · Traditional | Hardy Media | 03/31/1988SE |
| K880120 | Moellers Decarboxylase, LysineJSF · Traditional | Hardy Media | 03/31/1988SE |
| K880119 | Moellers Decarboxylase, OnithineJSF · Traditional | Hardy Media | 03/31/1988SE |
| K880139 | Onpg Test ReagentJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880135 | Nitrate BrothJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880129 | Brilliant Green Bile BrothJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880118 | Moelloers Decarboxylase, ArginineJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880113 | Cystine Tryptic Medium W/LactoseJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880112 | Cystine Tryptic Medium W/ MaltoseJSF · Traditional | Hardy Media | 03/30/1988SE |
More from Hardy Media
| 510(k) | Device | Decision |
|---|---|---|
| K864255 | Trypticase Soy BrothJSG · 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 Tryptone Water (1%) cleared by the FDA?
Tryptone Water (1%) (K864256) 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 K864256?
The FDA product code is JSF – Culture Media, Single Biochemical Test, a Class I (low risk) device regulated under 21 CFR 866.2320.