CRAG LATERAL FLOW ASSAY (LFA)— 510(k) K112422
Substantially EquivalentImmuno-Mycologics, Inc.
FDA 510(k) clearance K112422 for CRAG LATERAL FLOW ASSAY (LFA), Substantially Equivalent on 2012-03-28. Applicant: Immuno-Mycologics, Inc.. Device class: 2.
Clearance details
- Applicant
- Immuno-Mycologics, Inc.
- Product code
- Code GMD
- Device class
- Class 2
- Regulation
- 21 CFR 866.3165
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norman, OK, US
Recent devices under product code GMD
view allMore clearances from Immuno-Mycologics, Inc.
view allRecalls naming K112422
K-number listed on FDA's recall record- Z-0545-2022 — CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919
- Z-2409-2018 — Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.
- Z-1109-2017 — Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112422.
Data sourced from openFDA. This site is unofficial and independent of the FDA.