Todd-Hewitt Broth (0.5ML)#3099 & (5.OML)#T3516
FDA 510(k) K874538 · Lakewood Biochemical Co., Inc.
510(k) numberK874538
Submission
- Device name
- Todd-Hewitt Broth (0.5ML)#3099 & (5.OML)#T3516
- Applicant
- Lakewood Biochemical Co., Inc.
Dallas, TX, US - Received
- November 3, 1987
- Decision date
- November 20, 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 |
|---|---|---|
| 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 |
| K880946 | Nutrient Gelatin - Product Number T2860JSF · 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 |
| 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 Todd-Hewitt Broth (0.5ML)#3099 & (5.OML)#T3516 cleared by the FDA?
Todd-Hewitt Broth (0.5ML)#3099 & (5.OML)#T3516 (K874538) received a 510(k) decision of Substantially Equivalent on November 20, 1987, 17 days after the submission was received.
What is the product code of K874538?
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.