510(k) K954755
- Device
- COAT-A-COUNT DIRECT ANDROSTENEDIONE
- Applicant
- DIAGNOSTIC PRODUCTS CORP.
- 510(k) number
- K954755
- Product code
- CIZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-11-29
- Date received
- 1995-10-16
- Regulation
- 862.1075
- Classification name
- Radioimmunoassay, Androstenedione
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- EDWARD M LEVINE
- Address
- 5700 W. 96th St. Los Angeles CA US 90045 90045
FDA Registration Numbers#
- 1219913
- 3022178699
- 3002806944
- 8010132
- 3002800697
- 3007361513
- 2029372
- 9610126
- 2245285
- 2020726
- 8021924
- 3009335633
- 3005542422
- 1222302
- 2182595
- 2133982
- 2419955
- 3007118747
- 2432235
Source Documents#
Other 510(k) Records For Product Code CIZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K963002 | ACTIVE ANDROSTENEDIONE EIA | Diagnostic Systems Laboratories, Inc. | 1996-08-16 |
| K934751 | ACTIVE ANDROSTANEDIOL GLUCURONIDE | Diagnostic Systems Laboratories, Inc. | 1994-01-10 |
| K860559 | ANDROSTENEDIONE 125I KIT BY RIA | Immuchem Corp. | 1986-03-14 |
| K854673 | DSL ANDROSTENEDIONE RIA (DSL # 4200) | Diagnostic Systems Laboratories, Inc. | 1986-01-22 |
| K854650 | DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) | Diagnostic Systems Laboratories, Inc. | 1985-12-13 |
| K844398 | COAT-A-COUNT ANDROSTENEDIONE RIA KIT | Diagnostic Products Corp. | 1984-12-10 |
| K842960 | ANDROSTENEDIONE BY RIA | Radioassay Systems Laboratories, Inc. | 1984-09-27 |
| K832452 | ANDROSTENEDIONE TEST SET 125I | Wien Laboratories, Inc. | 1983-09-12 |
| K801729 | ANDROSTENEDIONE RADIOIMMUNOASSAY KIT | Diagnostics Biochem Canada, Inc. | 1980-10-31 |
Legacy Summary#
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FDA Review#
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