Emit II Plus Opiate Assay, Model OSR9B229
FDA 510(k) K011289 · Syva Co., Dade Behring, Inc.
510(k) numberK011289
Submission
- Device name
- Emit II Plus Opiate Assay, Model OSR9B229
- Applicant
- Syva Co., Dade Behring, Inc.
San Jose, CA, US - Received
- April 27, 2001
- Decision date
- May 15, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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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| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardDJG · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 05/10/2024SE |
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| 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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| K011920 | Emit 2000 Digoxin Assay, Model OSR4H229KXT · Special | 07/02/2001SE |
| K011620 | Emit 2000 N-Acetylprocainamide Assay, Model OSR4N229LAN · Special | 06/18/2001SE |
| K011605 | Emit 2000 Quinidine Assay, Model OSR4Q229LBZ · Special | 06/12/2001SE |
| K011300 | Emit II Plus Cannabinoid Assay, Model OSR9N229LDJ · Special | 05/17/2001SE |
| K011306 | Emit II Plus Benzodiazepine Assay, Model 0SR9F229JXM · Special | 05/16/2001SE |
| K011161 | Modification to the Emit II Plus Phencyclidine Assay, Model OSR9J229LCM · Special | 05/15/2001SE |
| K011166 | Modification to Emit 2000 Theophylline Assay, Model Osr 4P229KLS · Special | 05/10/2001SE |
| K011164 | Modification to the Emit II Plus Methaqualone Assay, Model OSR9Q229KXS · Special | 05/10/2001SE |
| K011163 | Modification to the Emit II Plus Propoxyphene Assay, Model OSR9G229JXN · Special | 05/10/2001SE |
| K011162 | Modification to the Emit II Plus Cocaine Metabolite AssayDIO · Special | 05/02/2001SE |
Questions and answers
When was Emit II Plus Opiate Assay, Model OSR9B229 cleared by the FDA?
Emit II Plus Opiate Assay, Model OSR9B229 (K011289) received a 510(k) decision of Substantially Equivalent on May 15, 2001, 18 days after the submission was received.
What is the product code of K011289?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.