Campy Broth
FDA 510(k) K880107 · Hardy Media
510(k) numberK880107
Submission
- Device name
- Campy Broth
- Applicant
- Hardy Media
Santa Barbara, CA, US - Received
- January 6, 1988
- Decision date
- March 30, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSD – Culture Media, Selective Broth
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
Other 510(k)s with product code JSD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883075 | Fastidious Inoculum BrothJSD · Traditional | Baxter Healthcare Corp | 08/15/1988SE |
| K873324 | Sabouraud Dextrose (SD) Broth Tube, #T3331JSD · Traditional | Lakewood Biochemical Co., Inc. | 10/02/1987SE |
| K873218 | Brain Heart Infusion Broth W/6.5% NAC1 - #T3802JSD · Traditional | Lakewood Biochemical Co., Inc. | 09/23/1987SE |
| K871640 | Alkaline Peptone WaterJSD · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/13/1987SE |
| K871447 | Todd Hewitt W/Cna (Lim Broth)JSD · Traditional | Remel Co. | 05/13/1987SE |
| K870594 | T9802 TSB W/6.5% NaclJSD · Traditional | Lakewood Biochemical Co., Inc. | 03/30/1987SE |
| K853609 | Apl Tryptic Soy BrothJSD · Traditional | Apl Medical Supplies | 09/12/1985SE |
| K844547 | Tryptic Soy Broth W/6.5%SODIUM ChlorideJSD · Traditional | bioMerieux, Inc. | 01/16/1985SE |
| K841836 | Selective Culture Med. TrichomonasJSD · Traditional | Microline Scientific | 05/14/1984SE |
| K840971 | Selective Culture MediumJSD · Traditional | Chatham Biological | 04/13/1984SE |
More from Chatham Biological
| 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 |
| K880124 | Lowenstein-Jensen, W/NaclJSJ · 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 |
Questions and answers
When was Campy Broth cleared by the FDA?
Campy Broth (K880107) received a 510(k) decision of Substantially Equivalent on March 30, 1988, 84 days after the submission was received.
What is the product code of K880107?
The FDA product code is JSD – Culture Media, Selective Broth, a Class I (low risk) device regulated under 21 CFR 866.2360.