Opiates Micro-Plate Assay
FDA 510(k) K935565 · Solarcare Technologies Corp,Inc.
510(k) numberK935565
Submission
- Device name
- Opiates Micro-Plate Assay
- Applicant
- Solarcare Technologies Corp,Inc.
Bethlehem, PA, US - Received
- November 18, 1993
- Decision date
- July 14, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Opiates Micro-Plate Assay cleared by the FDA?
Opiates Micro-Plate Assay (K935565) received a 510(k) decision of Substantially Equivalent on July 14, 1995, 603 days after the submission was received.
What is the product code of K935565?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.