Lombard Dowell Agar Base
FDA 510(k) K864014 · Gibco Laboratories Life Technologies, Inc.
510(k) numberK864014
Submission
- Device name
- Lombard Dowell Agar Base
- Applicant
- Gibco Laboratories Life Technologies, Inc.
Madison, WI, US - Received
- October 15, 1986
- Decision date
- October 29, 1986
- 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 |
|---|---|---|
| K871855 | Sorbitol Macconkey (Smac) Agar, Dri & Pre-FormJSH · Traditional | 05/26/1987SE |
| K871541 | Martin-Lewis Agar W/Reduced Vancomycin C0226JTY · Traditional | 04/29/1987SE |
| K870134 | Mcbride Listeria Agar W/Cycloheximide, Dri & PreJSJ · Traditional | 02/04/1987SE |
| K864755 | Pseudomonas Cepacia Selective Agar, Dri & Pre-FormJSJ · Traditional | 01/05/1987SE |
| K863821 | Mueller Hinton Agar W/4%NACL and OxacillinJTZ · Traditional | 10/09/1986SE |
| K863820 | Dri-Form: Gbna Listeria Medium No. M22300JSJ · Traditional | 10/08/1986SE |
| K863289 | CDC Anaerobic Agar W/Sheep Blood, Kana-&VancomycinJSJ · Traditional | 09/03/1986SE |
| K862425 | Macconkey Agar W/Mug, Dri-Form and Pre-FormJSI · Traditional | 07/02/1986SE |
| K861058 | Sensititre Auto Id Plate, AP70JTO · Traditional | 05/20/1986SE |
| K861734 | Regan-Lowe AgarJSJ · Traditional | 05/16/1986SE |
Questions and answers
When was Lombard Dowell Agar Base cleared by the FDA?
Lombard Dowell Agar Base (K864014) received a 510(k) decision of Substantially Equivalent on October 29, 1986, 14 days after the submission was received.
What is the product code of K864014?
The FDA product code is KZI – Culture Media, Enriched, a Class I (low risk) device regulated under 21 CFR 866.2330.