510(k) K891167
- Device
- Coat-a-count(tm) Lsd Radioimmunoassay Kit
- Applicant
- DIAGNOSTIC PRODUCTS CORP.
- 510(k) number
- K891167
- Product code
- DLB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-05-03
- Date received
- 1989-03-06
- Regulation
- 862.3580
- Classification name
- Radioimmunoassay, Lsd (125-I)
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH B ASARCH
- Address
- 5700 W. 96th St. Los Angeles CA US 90045 90045
FDA Registration Numbers#
- 3005360469
- 9610529
- 3010939897
- 2517506
- 9610126
- 3006198300
- 3003795116
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K955814 | CEDIA DAU LSD ASSAY | Microgenics Corp. | 1996-02-09 |
| K954073 | STC DIAGNOSTICS LSD MICRO-PLATE EIA | Solarcare Technologies Corp,Inc. | 1995-11-29 |
| 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 |