Crypto-Lex System
FDA 510(k) K930418 · Trinity Laboratories, Inc.
510(k) numberK930418
Submission
- Device name
- Crypto-Lex System
- Applicant
- Trinity Laboratories, Inc.
Raleigh, NC, US - Received
- January 26, 1993
- Decision date
- February 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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| K102286 | Crag Lateral Flow Assay (Crag Lfa)GMD · Traditional | Immuno-Mycologics, Inc. | 07/20/2011SE |
| 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 |
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Questions and answers
When was Crypto-Lex System cleared by the FDA?
Crypto-Lex System (K930418) received a 510(k) decision of Substantially Equivalent on February 17, 1994, 387 days after the submission was received.
What is the product code of K930418?
The FDA product code is GMD – Antisera, Latex Agglutination, Cryptococcus Neoformans, a Class II (moderate risk) device regulated under 21 CFR 866.3165.