Tryptic Soy Broth W/6.5%SODIUM Chloride
FDA 510(k) K844547 · bioMerieux, Inc.
510(k) numberK844547
Submission
- Device name
- Tryptic Soy Broth W/6.5%SODIUM Chloride
- Applicant
- bioMerieux, Inc.
Addison, IL, US - Received
- November 21, 1984
- Decision date
- January 16, 1985
- 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 |
| K880107 | Campy BrothJSD · Traditional | Hardy Media | 03/30/1988SE |
| 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 |
| K841836 | Selective Culture Med. TrichomonasJSD · Traditional | Microline Scientific | 05/14/1984SE |
| K840971 | Selective Culture MediumJSD · Traditional | Chatham Biological | 04/13/1984SE |
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Questions and answers
When was Tryptic Soy Broth W/6.5%SODIUM Chloride cleared by the FDA?
Tryptic Soy Broth W/6.5%SODIUM Chloride (K844547) received a 510(k) decision of Substantially Equivalent on January 16, 1985, 56 days after the submission was received.
What is the product code of K844547?
The FDA product code is JSD – Culture Media, Selective Broth, a Class I (low risk) device regulated under 21 CFR 866.2360.