Emit II LSD Assay, Emit LSD Calibrators & Emit LSD Controls
FDA 510(k) K955448 · Behring Diagnostics, Inc.
510(k) numberK955448
Submission
- Device name
- Emit II LSD Assay, Emit LSD Calibrators & Emit LSD Controls
- Applicant
- Behring Diagnostics, Inc.
San Jose, CA, US - Received
- November 29, 1995
- Decision date
- February 23, 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 |
| 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 |
|---|---|---|
| K973832 | Opus HLH ControlsJJX · Traditional | 10/27/1997SE |
| K972929 | N Antiserum to Human AlbuminDCF · Traditional | 10/20/1997SE |
| K972840 | N Antiserum to Human TransferrinDDG · Traditional | 10/17/1997SE |
| K973202 | Modification of Opus Ferritin Test SystemDBF · Traditional | 09/12/1997SE |
| K972316 | Opus D-DimerGHH · Traditional | 09/09/1997SE |
| K972116 | Von Willebrand ReagentGGP · Traditional | 07/25/1997SE |
| K972011 | Opus EthanolDIC · Traditional | 07/22/1997SE |
| K971600 | Emit Calibrator B Level 1 (Cutoff)/Emit Calibrator B Level 2 (High)DKB · Traditional | 06/25/1997SE |
| K971596 | Emit II Opiates 300/2000 AssayDJG · Traditional | 06/25/1997SE |
| K964595 | Opus Psa Test SystemLTJ · Traditional | 06/24/1997SE |
Questions and answers
When was Emit II LSD Assay, Emit LSD Calibrators & Emit LSD Controls cleared by the FDA?
Emit II LSD Assay, Emit LSD Calibrators & Emit LSD Controls (K955448) received a 510(k) decision of Substantially Equivalent on February 23, 1996, 86 days after the submission was received.
What is the product code of K955448?
The FDA product code is DLB – Radioimmunoassay, Lsd (125-I), a Class II (moderate risk) device regulated under 21 CFR 862.3580.