Lab-Tek Jembec G.C. Culture System
FDA 510(k) K811382 · Miles Laboratories, Inc.
510(k) numberK811382
Submission
- Device name
- Lab-Tek Jembec G.C. Culture System
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- May 15, 1981
- Decision date
- June 16, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTY – Culture Media, For Isolation Of Pathogenic Neisseria
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.2410
- Specialty
- Microbiology
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| K950196 | Culture Media, for Isolation of Pathogenic NeisseriaJTY · Traditional | Bioclinical Systems, Inc. | 06/30/1995SE |
| K933122 | Microbiological Culture Media,Martin Lewis AgarJTY · Traditional | Bioclinical Systems, Inc. | 02/09/1994SE |
| K933121 | Microbiological Culture Media,Chocolate AgarJTY · Traditional | Bioclinical Systems, Inc. | 02/03/1994SE |
| K934331 | Thayer Martin, Modified Pill PocketJTY · Traditional | Hardy Diagnostics | 12/21/1993SE |
| K934330 | TransgrowJTY · Traditional | Hardy Diagnostics | 12/17/1993SE |
| K931864 | Martin Lewis with LinocmycinJTY · Traditional | Hardy Diagnostics | 12/15/1993SE |
| K881552 | Proteose No. 3 AgarJTY · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
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Questions and answers
When was Lab-Tek Jembec G.C. Culture System cleared by the FDA?
Lab-Tek Jembec G.C. Culture System (K811382) received a 510(k) decision of Substantially Equivalent on June 16, 1981, 32 days after the submission was received.
What is the product code of K811382?
The FDA product code is JTY – Culture Media, For Isolation Of Pathogenic Neisseria, a Class II (moderate risk) device regulated under 21 CFR 866.2410.