Atlas FDA

TREP-SURE TREPONEMAL ANTIBODY EIA

FDA 510(k) clearance K053570 · decided 2006-08-07

Clearance details

K-number
K053570
Device name
TREP-SURE TREPONEMAL ANTIBODY EIA
Applicant
Phoenix Biotech Corp.
Decision
Substantially Equivalent
Date received
2005-12-22
Decision date
2006-08-07
Days to decision
228 days
Clearance type
Traditional
Product code
LIP
Device class
2
Regulation number
866.3830
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
East Stroudsburg, PA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Phoenix Biotech Corp.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Access Syphilis (K241427)Beckman Coulter, Inc.2024-09-06
VITROS Immunodiagnostic Products Syphilis Reagent Pack (K241534)Ortho Clinical Diagnostics2024-08-28
Elecsys Syphilis (K211302)Roche Diagnostics2021-07-20
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set (K170413)Bio-Rad Laboratories2017-05-11
Elecsys Syphilis (K160910)Roche Diagnostics2016-07-28
Lumipulse G TP-N Immunoreaction Cartridge Set (K153145)Fujirebio Diagnostics,Inc.2016-07-05
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control (K153730)Abbott Laboratories2016-06-15
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG (K120439)Bio-Rad Laboratories, Inc.2012-03-14
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS (K112343)Siemens Healthcare Diagnostics, Inc.2012-01-20
SYPHILIS HEALTH CHECK (K102400)Diagnostics Direct, LLC2011-08-01
ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM (K102283)Zeus Scientific, Inc.2011-02-10
ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM (K093837)Zeus Scientific, Inc. (Zeus)2010-10-01

Recalls involving this device

No recalls on record reference this clearance.