Cedia Dau LSD Assay
FDA 510(k) K955814 · Microgenics Corp.
510(k) numberK955814
Submission
- Device name
- Cedia Dau LSD Assay
- Applicant
- Microgenics Corp.
Concord, CA, US - Received
- December 26, 1995
- Decision date
- February 9, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| K961436 | Abuscreen Online LSD Reagent (90 ML Test Kit)DLB · Traditional | Roche Diagnostic Systems, Inc. | 06/21/1996SE |
| K955448 | Emit II LSD Assay, Emit LSD Calibrators & Emit LSD ControlsDLB · Traditional | Behring Diagnostics, Inc. | 02/23/1996SE |
| 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 |
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Questions and answers
When was Cedia Dau LSD Assay cleared by the FDA?
Cedia Dau LSD Assay (K955814) received a 510(k) decision of Substantially Equivalent on February 9, 1996, 45 days after the submission was received.
What is the product code of K955814?
The FDA product code is DLB – Radioimmunoassay, Lsd (125-I), a Class II (moderate risk) device regulated under 21 CFR 862.3580.