510(k) K955814
- Device
- CEDIA DAU LSD ASSAY
- Applicant
- MICROGENICS CORP.
- 510(k) number
- K955814
- Product code
- DLB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-02-09
- Date received
- 1995-12-26
- Regulation
- 862.3580
- Classification name
- Radioimmunoassay, Lsd (125-i)
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY KONING
- Address
- 2380a Bisso Ln. Concord CA US 94520 94520
FDA Registration Numbers#
- 3010939897
- 9610126
- 3005360469
- 9610529
- 3006198300
- 2517506
- 3003795116
Source Documents#
Other 510(k) Records For Product Code DLB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K961436 | ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) | Roche Diagnostic Systems, Inc. | 1996-06-21 |
| K955448 | EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS | Behring Diagnostics, Inc. | 1996-02-23 |
| K954073 | STC DIAGNOSTICS LSD MICRO-PLATE EIA | Solarcare Technologies Corp,Inc. | 1995-11-29 |
| K891167 | COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT | Diagnostic Products Corp. | 1989-05-03 |
| K874270 | REVISED LABELING FOR LSD TEST KIT | Roche Diagnostic Systems, Inc. | 1987-11-13 |
| K860525 | ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD | Roche Diagnostic Systems, Inc. | 1986-04-11 |
Legacy Summary#
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FDA Review#
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