Emit 700 Opiate Assay
FDA 510(k) K843162 · Syva Co.
510(k) numberK843162
Submission
- Device name
- Emit 700 Opiate Assay
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- August 10, 1984
- Decision date
- September 14, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
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Questions and answers
When was Emit 700 Opiate Assay cleared by the FDA?
Emit 700 Opiate Assay (K843162) received a 510(k) decision of Substantially Equivalent on September 14, 1984, 35 days after the submission was received.
What is the product code of K843162?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.