Microbiological Culture Media,Chocolate Agar
FDA 510(k) K933121 · Bioclinical Systems, Inc.
510(k) numberK933121
Submission
- Device name
- Microbiological Culture Media,Chocolate Agar
- Applicant
- Bioclinical Systems, Inc.
Annapolis Junction, MD, US - Received
- June 25, 1993
- Decision date
- February 3, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K954986 | GC Base W/ 1% GchiJTY · Traditional | Remel, L.P. | 02/16/1996SE |
| 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 |
| 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 |
| K881527 | Casman Medium BaseJTY · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K950196 | Culture Media, for Isolation of Pathogenic NeisseriaJTY · Traditional | 06/30/1995SE |
| K945911 | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton AgarsJTZ · Traditional | 04/04/1995SE |
| K933122 | Microbiological Culture Media,Martin Lewis AgarJTY · Traditional | 02/09/1994SE |
| K873086 | Round 1JXA · Traditional | 08/24/1987SE |
| K860334 | Visi-Check HLH Test MonoclonalCEP · Traditional | 04/21/1986SE |
| K860333 | Micro-Elisa HLH Test Kit MonoclonalCEP · Traditional | 04/21/1986SE |
| K855227 | Micro-Eia Theophylline Test Kit MonoclonalKLS · Traditional | 04/11/1986SE |
| K854059 | Micro-Elisa HCG Est Kit Visi-Check HCG Test Kit NoJHI · Traditional | 01/13/1986SE |
| K854379 | Micro-Elisa TSH Test Kit-Visi-Check TSH Test KitJLW · Traditional | 01/07/1986SE |
| K850257 | BCS Glucose Colorimetric TestCGA · Traditional | 03/05/1985SE |
Questions and answers
When was Microbiological Culture Media,Chocolate Agar cleared by the FDA?
Microbiological Culture Media,Chocolate Agar (K933121) received a 510(k) decision of Substantially Equivalent on February 3, 1994, 223 days after the submission was received.
What is the product code of K933121?
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.