510(k) K071319
- Device
- I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02
- Applicant
- BIO-RAD, DIAGNOSTICS GRP.
- 510(k) number
- K071319
- Product code
- GGN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-06-26
- Date received
- 2007-05-10
- Regulation
- 864.5425
- Classification name
- Plasma, Coagulation Control
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARIA ZEBALLOS
- Address
- 9500 Jeronimo Rd. Irvine CA US 92618 92618
FDA Registration Numbers#
- 2084025
- 3003453957
- 2431530
- 9681518
- 1181121
- 3027645317
- 3003985394
- 3004434070
- 9610806
- 1618982
- 2245451
- 3008386529
- 3011325031
- 9710666
- 1217183
- 1832216
- 3014150341
- 1928890
- 1000340866
- 3005792925
- 1219738
- 3043088937
- 3005643513
- 3012348571
- 1219343
- 2016706
- 9610746
- 2184009
- 2245578
- 3003691680
- 1226774
- 3005261789
- 3037000637
- 3012289015
- 3043138885
- 1220649
- 2085064
- 3002721930
- 9610126
- 3005269352
- 8043599
- 3010127294
- 1718389
- 3019849102
Source Documents#
Other 510(k) Records For Product Code GGN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170864 | VALIDATE D-Dimer Calibration Verification / Linearity Test Kit | Maine Standards Company, LLC | 2017-06-21 |
| K163498 | VALIDATE Heparin Calibration Verification/Linearity Test Kit | Maine Standards Company, LLC | 2017-03-16 |
| K161316 | George King Coumadin Plasma | George King Bio-Medical, Inc. | 2017-02-23 |
| K162705 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | 2017-01-05 |
| K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test Kit | Maine Standards Company, LLC | 2016-06-03 |
| K150144 | VisuCon-F Low Fibrinogen Control Plasma | Affinity Biologicals, Inc. | 2016-03-06 |
| K142132 | POOL NORM | Diagnostics Stago S.A.S. | 2014-12-12 |
| K133582 | HEMOSIL D-DIMER HS 500 CONTROL | Instrumentation Laboratory | 2014-08-15 |
| K120977 | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC | International Technidyne Corp. | 2013-07-03 |
| K120900 | I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 | Cliniqa Corporation | 2013-05-31 |
| K120014 | STA- COAG CONTROL (N+ABN) PLUS | Diagnostica Stago, Inc. | 2013-03-14 |
| K113211 | HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL | Instrumentation Laboratory CO | 2012-01-04 |
| K110432 | VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN | Affinity Biologicals, Inc. | 2011-10-20 |
| K100716 | AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 | Aalto Scientific, Ltd. | 2011-06-23 |
| K093848 | PT-MULTI-CALIBRATOR, MODEL OPAT07 | Dade Behring, Inc. | 2010-12-20 |
Legacy Summary#
summary
FDA Review#
Decision Summary