Crag Lateral Flow Assay (Lfa)
FDA 510(k) K112422 · Immuno-Mycologics, Inc.
510(k) numberK112422
Submission
- Device name
- Crag Lateral Flow Assay (Lfa)
- Applicant
- Immuno-Mycologics, Inc.
Norman, OK, US - Received
- August 23, 2011
- Decision date
- March 28, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K792693 | Cryptococcus Neoformans Antiserum, LatexGMD · Traditional | Meridian Diagnostics, Inc. | 01/21/1980SE |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K120946 | Alpha Cryptococcal Antigen EiaMDU · Traditional | 12/17/2012SE |
| K102286 | Crag Lateral Flow Assay (Crag Lfa)GMD · Traditional | 07/20/2011SE |
| K101407 | Alpha Histoplasma Antigen Eia Model HAG102MIZ · Traditional | 07/19/2011SE |
| K883333 | Rabbit Plasma Fibrinogen (RPF) SupplementJTL · Traditional | 08/25/1988SE |
| K880029 | Exo-Antigen Identification System Cat.# EX1001KFH · Traditional | 02/24/1988SE |
| K843286 | Ei-Candida Enzyme Immunoassay EI1001LRF · Traditional | 10/01/1984SE |
| K831918 | La-Staph Identification SystemJWX · Traditional | 06/08/1983SE |
| K830837 | La-Histo Antibody System #Hl 1001GMJ · Traditional | 05/05/1983SE |
| K810510 | Ya-Crypto Antibody Tube AgglutinationGMD · Traditional | 03/20/1981SE |
| K802427 | La-Sporo Antibody SystemGMA · Traditional | 10/31/1980SE |
Questions and answers
When was Crag Lateral Flow Assay (Lfa) cleared by the FDA?
Crag Lateral Flow Assay (Lfa) (K112422) received a 510(k) decision of Substantially Equivalent on March 28, 2012, 218 days after the submission was received.
What is the product code of K112422?
The FDA product code is GMD – Antisera, Latex Agglutination, Cryptococcus Neoformans, a Class II (moderate risk) device regulated under 21 CFR 866.3165.