Usdt Opiate Assay Column Catalog No. 9000-200
FDA 510(k) K932318 · U.S. Drug Testing, Inc.
510(k) numberK932318
Submission
- Device name
- Usdt Opiate Assay Column Catalog No. 9000-200
- Applicant
- U.S. Drug Testing, Inc.
Rancho Cucamonga, CA, US - Received
- May 11, 1993
- Decision date
- June 15, 1993
- 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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More from Shanghai Accurature Diagnostics Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K940912 | Usdt Cannabinoid (THC) Assay Column Catalog No. 9000-500LDJ · Traditional | 06/02/1994SE |
| K935629 | Usdt Phencyclidine (PCP) Assay Column Cat. No. 9000-400LCM · Traditional | 04/12/1994SE |
| K934693 | Amphetamine Test SystemDKZ · Traditional | 11/22/1993SE |
| K931227 | Usdt Flow Immunoassay System, Model 9000KZR · Traditional | 05/06/1993SE |
| K930985 | Usdt Cocaine/Cocaine Metabol Assay COLUMN,9000-100DIO · Traditional | 04/27/1993SE |
Questions and answers
When was Usdt Opiate Assay Column Catalog No. 9000-200 cleared by the FDA?
Usdt Opiate Assay Column Catalog No. 9000-200 (K932318) received a 510(k) decision of Substantially Equivalent on June 15, 1993, 35 days after the submission was received.
What is the product code of K932318?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.