DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)
FDA 510(k) clearance K854650 · decided 1985-12-13
Clearance details
- K-number
- K854650
- Device name
- DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)
- Applicant
- Diagnostic Systems Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-11-19
- Decision date
- 1985-12-13
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- CIZ
- Device class
- 1
- Regulation number
- 862.1075
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Webster, TX, 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 |
|---|---|---|
| ACTIVE ANDROSTENEDIONE EIA (K963002) | Diagnostic Systems Laboratories, Inc. | 1996-08-16 |
| COAT-A-COUNT DIRECT ANDROSTENEDIONE (K954755) | Diagnostic Products Corp. | 1995-11-29 |
| ACTIVE ANDROSTANEDIOL GLUCURONIDE (K934751) | Diagnostic Systems Laboratories, Inc. | 1994-01-10 |
| ANDROSTENEDIONE 125I KIT BY RIA (K860559) | Immuchem Corp. | 1986-03-14 |
| DSL ANDROSTENEDIONE RIA (DSL # 4200) (K854673) | Diagnostic Systems Laboratories, Inc. | 1986-01-22 |
| COAT-A-COUNT ANDROSTENEDIONE RIA KIT (K844398) | Diagnostic Products Corp. | 1984-12-10 |
| ANDROSTENEDIONE BY RIA (K842960) | Radioassay Systems Laboratories, Inc. | 1984-09-27 |
| ANDROSTENEDIONE TEST SET 125I (K832452) | Wien Laboratories, Inc. | 1983-09-12 |
| ANDROSTENEDIONE RADIOIMMUNOASSAY KIT (K801729) | Diagnostics Biochem Canada, Inc. | 1980-10-31 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of recall (Z-0704-05) | Diasorin Inc. | 2005-04-13 |
| DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725, DiaSorin Stillwat recall (Z-0634-05) | Diasorin Inc. | 2005-03-18 |