Atlas FDA

INCSTAR 25-HYDROXYVITMIN D 1251 RIA

FDA 510(k) clearance K953567 · decided 1996-09-25

Clearance details

K-number
K953567
Device name
INCSTAR 25-HYDROXYVITMIN D 1251 RIA
Applicant
Incstar Corp.
Decision
Substantially Equivalent
Date received
1995-07-31
Decision date
1996-09-25
Days to decision
422 days
Clearance type
Traditional
Product code
MRG
Device class
2
Regulation number
862.1825
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Stillwater, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Mi recall (Z-1237-2007)Diasorin Inc.2007-09-20

PMA approvals by this applicant

RecordFirmDate
CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ] (P790032/S003)Incstar Corp.1993-07-23
CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ] (P790032/S002)Incstar Corp.1991-03-28
GAMMA DAB (125I) AFP RIA KIT (P790032/S001)Incstar Corp.1986-08-22
GAMMA DAB (125I) AFP RIA KIT (P790032)Incstar Corp.1986-04-30