Premier-Cryptococcal Antigen
FDA 510(k) K904393 · Meridian Diagnostics, Inc.
510(k) numberK904393
Submission
- Device name
- Premier-Cryptococcal Antigen
- Applicant
- Meridian Diagnostics, Inc.
Cincinnati, OH, US - Received
- September 25, 1990
- Decision date
- January 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MDU – Antigen, Elisa, Cryptococcus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3165
- Specialty
- Microbiology
Other 510(k)s with product code MDU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120946 | Alpha Cryptococcal Antigen EiaMDU · Traditional | Immuno-Mycologics, Inc. | 12/17/2012SE |
More from Immuno-Mycologics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K993914 | Premier Toxins A&B, Model 616096LLH · Special | 12/10/1999SE |
| K990263 | Immunocard Stat! E. Coli O157:H7GMZ · Traditional | 08/09/1999SE |
| K984346 | Premier Type Specific HSV-2 Igg Elisa TestLGC · Traditional | 06/25/1999SE |
| K984343 | Premier Type Specific HSV-1 Igg Elisa TestMXJ · Traditional | 06/25/1999SE |
| K983255 | Modification to: Premier Platinum HpsaLYR · Traditional | 12/17/1998SE |
| K982764 | Premier CryptosporidiumMHJ · Traditional | 12/03/1998SE |
| K982711 | Premier GiardiaMHI · Traditional | 11/25/1998SE |
| K980076 | Premier Platinum HpsaLYR · Traditional | 05/12/1998SE |
| K980077 | Para-Pak SpinconLKS · Traditional | 04/02/1998SE |
| K971585 | Immunocard Stat! RotavirusLIQ · Traditional | 08/20/1997SE |
Questions and answers
When was Premier-Cryptococcal Antigen cleared by the FDA?
Premier-Cryptococcal Antigen (K904393) received a 510(k) decision of Substantially Equivalent on January 25, 1991, 122 days after the submission was received.
What is the product code of K904393?
The FDA product code is MDU – Antigen, Elisa, Cryptococcus, a Class II (moderate risk) device regulated under 21 CFR 866.3165.