Tryptic Soy Agar
FDA 510(k) K832611 · Carroll Biological Corp.
510(k) numberK832611
Submission
- Device name
- Tryptic Soy Agar
- Applicant
- Carroll Biological Corp.
Mchenry, IL, US - Received
- July 8, 1983
- Decision date
- September 12, 1983
- 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 |
|---|---|---|
| K832243 | Culture Medium for Antimicrobial SusJTZ · Traditional | 09/29/1983SE |
| K832620 | Tryptic Soy Broth MediaJSC · Traditional | 09/12/1983SE |
| K832619 | Thioglycollate MediumJSC · Traditional | 09/12/1983SE |
| K832618 | Blue AgarJSI · Traditional | 09/12/1983SE |
| K832617 | Xylose Lysine DeoxycholateJSI · Traditional | 09/12/1983SE |
| K832616 | Macconkey Agar MediaJSH · Traditional | 09/12/1983SE |
| K832615 | SF BrothJSJ · Traditional | 09/12/1983SE |
| K832614 | Selenite BrothJSJ · Traditional | 09/12/1983SE |
| K832613 | Mannitol Salt AgarJSJ · Traditional | 09/12/1983SE |
| K832612 | Chocolate Agar & Thayer Martin AgarJTY · Traditional | 09/12/1983SE |
Questions and answers
When was Tryptic Soy Agar cleared by the FDA?
Tryptic Soy Agar (K832611) received a 510(k) decision of Substantially Equivalent on September 12, 1983, 66 days after the submission was received.
What is the product code of K832611?
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.