Atlas FDA

COAT-A-COUNT DIRECT ANDROSTENEDIONE

FDA 510(k) clearance K954755 · decided 1995-11-29

Clearance details

K-number
K954755
Device name
COAT-A-COUNT DIRECT ANDROSTENEDIONE
Applicant
Diagnostic Products Corp.
Decision
Substantially Equivalent
Date received
1995-10-16
Decision date
1995-11-29
Days to decision
44 days
Clearance type
Traditional
Product code
CIZ
Device class
1
Regulation number
862.1075
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Los Angeles, 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.

RecordFirmDate
ACTIVE ANDROSTENEDIONE EIA (K963002)Diagnostic Systems Laboratories, Inc.1996-08-16
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
DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) (K854650)Diagnostic Systems Laboratories, Inc.1985-12-13
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

RecordFirmDate
Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcar recall (Z-2058-2014)Siemens Healthcare Diagnostics Inc.2014-07-15