Lowenstein-Jensen, W/Nacl
FDA 510(k) K880124 · Hardy Media
510(k) numberK880124
Submission
- Device name
- Lowenstein-Jensen, W/Nacl
- Applicant
- Hardy Media
Santa Barbara, CA, US - Received
- January 6, 1988
- Decision date
- March 31, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSJ – Culture Media, Selective And Non-Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
Other 510(k)s with product code JSJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882463 | Potato Dextrose Agar (Pda) - Product #P3421JSJ · Traditional | Lakewood Biochemical Co., Inc. | 06/22/1988SE |
| K881578 | StreptoselJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881574 | W-L Differential MediumJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881573 | Phytone Yeast Extract AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881571 | Ym BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881570 | Sabouraud Maltose AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881565 | Inhibitory Mold AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881561 | Tergitol 7 BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881549 | Mycological Agar W/Low PHJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881547 | Mitis Salivarius AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880134 | Middlebrook 7H11 AgarKZI · Traditional | 03/31/1988SE |
| K880133 | Mil MediumJSE · Traditional | 03/31/1988SE |
| K880131 | Lowenstein-Jensen, GruftKZI · Traditional | 03/31/1988SE |
| K880126 | Lauryl Tryptose BrothJSF · Traditional | 03/31/1988SE |
| K880125 | Lowenstein-Jensen, SelectiveJSI · Traditional | 03/31/1988SE |
| K880123 | Lowenstein-Jensen SlantJSJ · Traditional | 03/31/1988SE |
| K880122 | Middlebrook 7H9 BrothKZI · Traditional | 03/31/1988SE |
| K880121 | Moellers Decarboxylase, BaseJSH · Traditional | 03/31/1988SE |
| K880120 | Moellers Decarboxylase, LysineJSF · Traditional | 03/31/1988SE |
| K880119 | Moellers Decarboxylase, OnithineJSF · Traditional | 03/31/1988SE |
Questions and answers
When was Lowenstein-Jensen, W/Nacl cleared by the FDA?
Lowenstein-Jensen, W/Nacl (K880124) received a 510(k) decision of Substantially Equivalent on March 31, 1988, 85 days after the submission was received.
What is the product code of K880124?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.