Tryptone
FDA 510(k) K881557 · Acumedia Manufacturers, Inc.
510(k) numberK881557
Submission
- Device name
- Tryptone
- Applicant
- Acumedia Manufacturers, Inc.
Baltimore, MD, US - Received
- April 8, 1988
- Decision date
- April 18, 1988
- 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 |
| 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 |
| K881545 | Malt ExtractJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K881579 | Amies Transport Medium W/O CharcoalJSN · Traditional | 04/18/1988SE |
| K881578 | StreptoselJSJ · Traditional | 04/18/1988SE |
| K881577 | Modified Selective Streptococcus AgarJSI · Traditional | 04/18/1988SE |
| K881576 | Selenite BrothJSI · Traditional | 04/18/1988SE |
| K881575 | Selective Streptococcus AgarJSI · Traditional | 04/18/1988SE |
| K881574 | W-L Differential MediumJSJ · Traditional | 04/18/1988SE |
| K881573 | Phytone Yeast Extract AgarJSJ · Traditional | 04/18/1988SE |
| K881572 | XL Agar BaseJSI · Traditional | 04/18/1988SE |
| K881571 | Ym BrothJSJ · Traditional | 04/18/1988SE |
| K881570 | Sabouraud Maltose AgarJSJ · Traditional | 04/18/1988SE |
Questions and answers
When was Tryptone cleared by the FDA?
Tryptone (K881557) received a 510(k) decision of Substantially Equivalent on April 18, 1988, 10 days after the submission was received.
What is the product code of K881557?
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.