Atlas FDA

LUPO-TEST REGEANT

FDA 510(k) clearance K922326 · decided 1993-04-06

Clearance details

K-number
K922326
Device name
LUPO-TEST REGEANT
Applicant
Graoipore , Ltd.
Decision
Substantially Equivalent
Date received
1992-05-11
Decision date
1993-04-06
Days to decision
330 days
Clearance type
Traditional
Product code
GIR
Device class
1
Regulation number
864.8950
Medical specialty
Hematology
Advisory committee
Hematology
Location
Pyrmont 2009 Australia, AU
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Graoipore

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
REAGENT, RUSSEL VIPER VENOM - LA CONFIRM (K132076)Dsrv, Inc.2014-01-10
REAGENT, RUSSEL VIPER VENOM - LA SCREEN (K132130)Dsrv, Inc.2014-01-10
HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM (K110031)Instrumentation Laboratory CO2011-08-24
LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA (K083878)R2 Diagnostics, Inc.2010-06-25
STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM (K061805)Diagnostica Stago, Inc.2006-12-06
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 (K000528)Sigma Diagnostics, Inc.2000-04-07
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 (K000527)Sigma Diagnostics, Inc.2000-04-07
CRYOCHECK LA SURE, MODEL SUR25-10 (K990580)Precision Biologic1999-07-28
CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) (K990579)Precision Biologic1999-07-23
IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) (K990302)Instrumentation Laboratory CO1999-04-08
DV TEST AND DVV CONFIRM (K940490)American Diagnostica, Inc.1995-04-05
BIOCLOT LA (K932463)Biopool AB1993-09-27

Recalls involving this device

No recalls on record reference this clearance.