Abuscreen Online LSD Reagent (90 ML Test Kit)
FDA 510(k) K961436 · Roche Diagnostic Systems, Inc.
510(k) numberK961436
Submission
- Device name
- Abuscreen Online LSD Reagent (90 ML Test Kit)
- Applicant
- Roche Diagnostic Systems, Inc.
Somerville, NJ, US - Received
- April 15, 1996
- Decision date
- June 21, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DLB – Radioimmunoassay, Lsd (125-I)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3580
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DLB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955448 | Emit II LSD Assay, Emit LSD Calibrators & Emit LSD ControlsDLB · Traditional | Behring Diagnostics, Inc. | 02/23/1996SE |
| K955814 | Cedia Dau LSD AssayDLB · Traditional | Microgenics Corp. | 02/09/1996SE |
| K954073 | STC Diagnostics LSD Micro-Plate EiaDLB · Traditional | Solarcare Technologies Corp,Inc. | 11/29/1995SE |
| K891167 | Coat-A-Count(Tm) LSD Radioimmunoassay KitDLB · Traditional | Diagnostic Products Corp. | 05/03/1989SE |
| K874270 | Revised Labeling for LSD Test KitDLB · Traditional | Roche Diagnostic Systems, Inc. | 11/13/1987SE |
| K860525 | Abuscreen Radioimmunoassay for LSD W/ Ref StandardDLB · Traditional | Roche Diagnostic Systems, Inc. | 04/11/1986SE |
More from Roche Diagnostic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983698 | Modification to Abuscreen Online BarbituratesDIS · Traditional | 05/03/1999SE |
| K983702 | Modification to Abuscreen Online for BenzoidiazepinesJXM · Traditional | 02/11/1999SE |
| K983704 | Modification to Abuscreen Online for PhencyclidineJCM · Traditional | 02/10/1999SE |
| K983556 | Abuscreen Online Benz 300 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983555 | Abuscreen Online Benz 200 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983703 | Modification to Abuscreen Online for MethadoneDJR · Special | 12/11/1998SE |
| K983701 | Modification to Abuscreen Online for CannabinoidsLDJ · Special | 12/11/1998SE |
| K983700 | Modification to Abuscreen Online for PropoxypheneJXN · Special | 12/11/1998SE |
| K983699 | Modification to Abuscreen Online for AmphetaminesDKZ · Special | 12/11/1998SE |
| K983697 | Modification to Abuscreen Online Cocaine MetaboliteDIO · Special | 12/11/1998SE |
Questions and answers
When was Abuscreen Online LSD Reagent (90 ML Test Kit) cleared by the FDA?
Abuscreen Online LSD Reagent (90 ML Test Kit) (K961436) received a 510(k) decision of Substantially Equivalent on June 21, 1996, 67 days after the submission was received.
What is the product code of K961436?
The FDA product code is DLB – Radioimmunoassay, Lsd (125-I), a Class II (moderate risk) device regulated under 21 CFR 862.3580.