Nutrient Gelatin - Product Number T2860
FDA 510(k) K880946 · Lakewood Biochemical Co., Inc.
510(k) numberK880946
Submission
- Device name
- Nutrient Gelatin - Product Number T2860
- Applicant
- Lakewood Biochemical Co., Inc.
Dallas, TX, US - Received
- March 7, 1988
- Decision date
- April 1, 1988
- 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 |
|---|---|---|---|
| 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 |
| K880111 | Cystine Tryptic Medium W/SucroseJSF · Traditional | Hardy Media | 03/30/1988SE |
More from Hardy Media
| 510(k) | Device | Decision |
|---|---|---|
| K882495 | Thioglycollate Broth W/Vita. K & Hemin - #T3007JSG · Traditional | 07/01/1988SE |
| K882351 | Mueller Hinton Agar Plates P3318/1&2/P3418/P34181JTZ · Traditional | 06/28/1988SE |
| K882463 | Potato Dextrose Agar (Pda) - Product #P3421JSJ · Traditional | 06/22/1988SE |
| K882182 | Salmonella-Shigella (SS) Agar - Product #P3326JSI · Traditional | 06/06/1988SE |
| K880947 | Nutrient Agar Plate, Slant Tube and Broth TubeJSG · Traditional | 04/01/1988SE |
| K880945 | Camplyobacter Culture Media Products P3873/T3597JSJ · Traditional | 03/30/1988SE |
| K875136 | Columbia Blood Agar P3308/ Columbia Cna P3750JSG · Traditional | 01/12/1988SE |
| K874538 | Todd-Hewitt Broth (0.5ML)#3099 & (5.OML)#T3516JSG · Traditional | 11/20/1987SE |
| K874537 | Kligler Iron Agar and Triple Sugar Iron AgarJSE · Traditional | 11/20/1987SE |
| K874345 | Tsa W/Neomycin & 5% Sheep Blood - # P3104 & Z3050JSJ · Traditional | 11/06/1987SE |
Questions and answers
When was Nutrient Gelatin - Product Number T2860 cleared by the FDA?
Nutrient Gelatin - Product Number T2860 (K880946) received a 510(k) decision of Substantially Equivalent on April 1, 1988, 25 days after the submission was received.
What is the product code of K880946?
The FDA product code is JSF – Culture Media, Single Biochemical Test, a Class I (low risk) device regulated under 21 CFR 866.2320.