Immunalysis Amphetamine Elisa for Oral Fluids
FDA 510(k) K051579 · Immunalysis Corporation
510(k) numberK051579
Submission
- Device name
- Immunalysis Amphetamine Elisa for Oral Fluids
- Applicant
- Immunalysis Corporation
Pomona, CA, US - Received
- June 14, 2005
- Decision date
- October 21, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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| K252520 | SEFRIA Hydrocodone Oral FluidDJG · Traditional | 09/11/2025SE |
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| K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIAQBK · Traditional | 11/15/2019SE |
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| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM · Traditional | 01/24/2019SE |
Questions and answers
When was Immunalysis Amphetamine Elisa for Oral Fluids cleared by the FDA?
Immunalysis Amphetamine Elisa for Oral Fluids (K051579) received a 510(k) decision of Substantially Equivalent on October 21, 2005, 129 days after the submission was received.
What is the product code of K051579?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.