Immulite Amphetamine, Models LKAM1, LKAM5
FDA 510(k) K992632 · Diagnostic Products Corp.
510(k) numberK992632
Submission
- Device name
- Immulite Amphetamine, Models LKAM1, LKAM5
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- August 6, 1999
- Decision date
- January 27, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | 12/09/2002SE |
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Questions and answers
When was Immulite Amphetamine, Models LKAM1, LKAM5 cleared by the FDA?
Immulite Amphetamine, Models LKAM1, LKAM5 (K992632) received a 510(k) decision of Substantially Equivalent on January 27, 2000, 174 days after the submission was received.
What is the product code of K992632?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.