IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)
FDA 510(k) clearance K990302 · decided 1999-04-08
Clearance details
- K-number
- K990302
- Device name
- IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 1999-02-01
- Decision date
- 1999-04-08
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- GIR
- Device class
- 1
- Regulation number
- 864.8950
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Lexington, MA, 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.
| Record | Firm | Date |
|---|---|---|
| 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 CO | 2011-08-24 |
| 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 Biologic | 1999-07-28 |
| CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) (K990579) | Precision Biologic | 1999-07-23 |
| DV TEST AND DVV CONFIRM (K940490) | American Diagnostica, Inc. | 1995-04-05 |
| BIOCLOT LA (K932463) | Biopool AB | 1993-09-27 |
| LUPO-TEST REGEANT (K922326) | Graoipore , Ltd. | 1993-04-06 |
Recalls involving this device
No recalls on record reference this clearance.