Atlas FDA

TREPCHEK TREPONEMAL ANTIBODY EIA

FDA 510(k) clearance K001552 · decided 2000-10-19

Clearance details

K-number
K001552
Device name
TREPCHEK TREPONEMAL ANTIBODY EIA
Applicant
Phoenix Biotech Corp.
Decision
Substantially Equivalent
Date received
2000-05-18
Decision date
2000-10-19
Days to decision
154 days
Clearance type
Traditional
Product code
LIP
Device class
2
Regulation number
866.3830
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Blairstown, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. recall (Z-0784-05)Diasorin Inc.2005-04-28
The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for recall (Z-0325-05)Diamedix Corporation2004-12-17
Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, recall (Z-0513-04)Diamedix Corporation2004-07-20