Cryptococcus Neoformans Antiserum, Latex
FDA 510(k) K792693 · Meridian Diagnostics, Inc.
510(k) numberK792693
Submission
- Device name
- Cryptococcus Neoformans Antiserum, Latex
- Applicant
- Meridian Diagnostics, Inc.
Mchenry, IL, US - Received
- December 27, 1979
- Decision date
- January 21, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GMD – Antisera, Latex Agglutination, Cryptococcus Neoformans
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3165
- Specialty
- Microbiology
Other 510(k)s with product code GMD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K112422 | Crag Lateral Flow Assay (Lfa)GMD · Traditional | Immuno-Mycologics, Inc. | 03/28/2012SE |
| K102286 | Crag Lateral Flow Assay (Crag Lfa)GMD · Traditional | Immuno-Mycologics, Inc. | 07/20/2011SE |
| K930418 | Crypto-Lex SystemGMD · Traditional | Trinity Laboratories, Inc. | 02/17/1994SE |
| K933997 | Prospect Entamoeba Histolytica Microplate AssayGMD · Traditional | Alexon Biomedical, Inc. | 11/22/1993SE |
| K894845 | (Calas(Tm)) W/Add'L Reagent Calas(Tm) PronaseGMD · Traditional | Meridian Diagnostics, Inc. | 09/08/1989SE |
| K812188 | Cryptococcal Antigen Latex AgglutiGMD · Traditional | American Scientific Products | 08/31/1981SE |
| K810510 | Ya-Crypto Antibody Tube AgglutinationGMD · Traditional | Immuno-Mycologics, Inc. | 03/20/1981SE |
| K791382 | Cryptococcal Antigen Latex AgglutinationGMD · Traditional | Immuno-Mycologics, Inc. | 08/16/1979SE |
| K780526 | Cryptococcal Antigen Latex Agg. SystemGMD · Traditional | I M, Inc. | 04/28/1978SE |
More from I M, Inc.
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| 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 Cryptococcus Neoformans Antiserum, Latex cleared by the FDA?
Cryptococcus Neoformans Antiserum, Latex (K792693) received a 510(k) decision of Substantially Equivalent on January 21, 1980, 25 days after the submission was received.
What is the product code of K792693?
The FDA product code is GMD – Antisera, Latex Agglutination, Cryptococcus Neoformans, a Class II (moderate risk) device regulated under 21 CFR 866.3165.