510(k) K992851
- Device
- ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
- Applicant
- ROCHE DIAGNOSTICS CORP.
- 510(k) number
- K992851
- Product code
- JBP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-01-14
- Date received
- 1999-08-24
- Regulation
- 864.7140
- Classification name
- Activated Whole Blood Clotting Time
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LUANN OCHS
- Address
- 9115 Hague Rd., P.O. Box 50457 Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 3002721930
- 3005643513
- 1649914
- 1217183
- 1719400
- 3006198300
- 1219343
- 2184009
- 2245578
- 1928237
- 1644474
- 1618982
- 1718389
- 3019849102
Source Documents#
Other 510(k) Records For Product Code JBP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223635 | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer | Sienco, Inc. | 2023-01-04 |
| K062604 | RAPIDTEG TEG-ACT TEST | Haemoscope Corp. | 2007-01-31 |
| K032952 | AIACT KIT | Sienco, Inc. | 2003-12-12 |
| K023582 | I-STAT KAOLIN ACT TEST | I-Stat Corporation | 2003-09-08 |
| K020914 | ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 | Helena Laboratories | 2002-05-23 |
| K013078 | ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 | Helena Laboratories | 2002-01-10 |
| K002528 | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION | Sienco, Inc. | 2000-08-31 |
| K994194 | (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT | Cardiovascular Diagnostics, Inc. | 2000-03-28 |
| K992571 | I-STAT SYSTEM | I-Stat Corp. | 2000-02-10 |
| K984141 | GBACT + KIT | Sienco, Inc. | 1999-05-28 |
| K983649 | MAX-ACT | Array Medical, Inc. | 1998-12-11 |
| K971935 | B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) | B & D Corp. | 1997-10-01 |
| K964609 | ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE | Array Medical, Inc. | 1997-03-06 |
| K960749 | HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT | International Technidyne Corp. | 1996-08-12 |
| K941007 | CATALOG NO. J-ACT+ & QC-ACT+ | International Technidyne Corp. | 1994-06-30 |
Legacy Summary#
summary
FDA Review#
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