Beta-Cell
FDA 510(k) K791607 · Biologics Intl., Inc.
510(k) numberK791607
Submission
- Device name
- Beta-Cell
- Applicant
- Biologics Intl., Inc.
Mchenry, IL, US - Received
- August 14, 1979
- Decision date
- September 24, 1979
- 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 |
|---|---|---|
| K882229 | Air Bed & Flotation Dermagard 800 & 900 SystemsIOQ · Traditional | 08/16/1988SE |
| K823353 | Carcino-CekJJX · Traditional | 12/14/1982SE |
| K812060 | Bi-Aso Slide TestGTQ · Traditional | 08/13/1981SE |
| K811375 | Bi-Ra Slide TestDHR · Traditional | 06/12/1981SE |
| K811374 | Bi-Crp Latex TestDCN · Traditional | 06/12/1981SE |
| K800605 | Ana Latex Slide TestDHC · Traditional | 04/02/1980SE |
| K791609 | Be-SureJHJ · Traditional | 10/02/1979SE |
| K790898 | Preg-TexJHJ · Traditional | 07/30/1979SE |
Questions and answers
When was Beta-Cell cleared by the FDA?
Beta-Cell (K791607) received a 510(k) decision of Substantially Equivalent on September 24, 1979, 41 days after the submission was received.
What is the product code of K791607?
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.