EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS
FDA 510(k) clearance K955448 · decided 1996-02-23
Clearance details
- K-number
- K955448
- Device name
- EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS
- Applicant
- Behring Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-29
- Decision date
- 1996-02-23
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- DLB
- Device class
- 2
- Regulation number
- 862.3580
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) (K961436) | Roche Diagnostic Systems, Inc. | 1996-06-21 |
| CEDIA DAU LSD ASSAY (K955814) | Microgenics Corp. | 1996-02-09 |
| STC DIAGNOSTICS LSD MICRO-PLATE EIA (K954073) | Solarcare Technologies Corp,Inc. | 1995-11-29 |
| COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT (K891167) | Diagnostic Products Corp. | 1989-05-03 |
| REVISED LABELING FOR LSD TEST KIT (K874270) | Roche Diagnostic Systems, Inc. | 1987-11-13 |
| ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD (K860525) | Roche Diagnostic Systems, Inc. | 1986-04-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OPUS(R) CEA TEST SYSTEM (P920021/S001) | Behring Diagnostics, Inc. | 1996-02-23 |