Biosite Diagnostics Opiate Screening Test
FDA 510(k) K902924 · Biosite Incorporated
510(k) numberK902924
Submission
- Device name
- Biosite Diagnostics Opiate Screening Test
- Applicant
- Biosite Incorporated
San Diego, CA, US - Received
- July 2, 1990
- Decision date
- September 14, 1990
- 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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| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardDJG · Traditional | Co-Innovation Biotech Co., Ltd. | 03/08/2024SE |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine…DJG · Traditional | Shanghai Accurature Diagnostics Co., Ltd. | 02/23/2024SE |
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Questions and answers
When was Biosite Diagnostics Opiate Screening Test cleared by the FDA?
Biosite Diagnostics Opiate Screening Test (K902924) received a 510(k) decision of Substantially Equivalent on September 14, 1990, 74 days after the submission was received.
What is the product code of K902924?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.