Tetrathionate Broth
FDA 510(k) K870634 · Hardy Media
510(k) numberK870634
Submission
- Device name
- Tetrathionate Broth
- Applicant
- Hardy Media
Santa Barbara, CA, US - Received
- February 13, 1987
- Decision date
- April 14, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KZI – Culture Media, Enriched
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2330
- Specialty
- Microbiology
Other 510(k)s with product code KZI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884208 | Listeria Selective Medium (Oxford Formulation)KZI · Traditional | Oxoid U.S.A., Inc. | 10/25/1988SE |
| K881995 | Diamond's Medium ModifiedKZI · Traditional | Remel Co. | 06/02/1988SE |
| K880134 | Middlebrook 7H11 AgarKZI · Traditional | Hardy Media | 03/31/1988SE |
| K880131 | Lowenstein-Jensen, GruftKZI · Traditional | Hardy Media | 03/31/1988SE |
| K880122 | Middlebrook 7H9 BrothKZI · Traditional | Hardy Media | 03/31/1988SE |
| K880138 | Wallenstein Medium SlantKZI · Traditional | Hardy Media | 03/30/1988SE |
| K880109 | Cystine Tryptic Medium BaseKZI · Traditional | Hardy Media | 03/30/1988SE |
| K880127 | Potato Dextrose AgarKZI · Traditional | Hardy Media | 03/07/1988SE |
| K874179 | Biotis (TM) Sabhi (Double Pour)KZI · Traditional | Otisville Biopharm, Inc. | 01/28/1988SE |
| K874177 | Biotis (TM) BcyeKZI · Traditional | Otisville Biopharm, Inc. | 12/04/1987SE |
More from Otisville Biopharm, 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 |
| 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 Tetrathionate Broth cleared by the FDA?
Tetrathionate Broth (K870634) received a 510(k) decision of Substantially Equivalent on April 14, 1987, 60 days after the submission was received.
What is the product code of K870634?
The FDA product code is KZI – Culture Media, Enriched, a Class I (low risk) device regulated under 21 CFR 866.2330.