THROMBIN CLOTTING TIME REAGENT
FDA 510(k) clearance K920147 · decided 1992-05-01
Clearance details
- K-number
- K920147
- Device name
- THROMBIN CLOTTING TIME REAGENT
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1992-01-13
- Decision date
- 1992-05-01
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- GJA
- Device class
- 2
- Regulation number
- 864.7875
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Beaumont, TX, 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 |
|---|---|---|
| T-TEK (K050817) | R2 Diagnostics, Inc. | 2005-12-12 |
| ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 (K982209) | Sigma Diagnostics, Inc. | 1998-10-15 |
| BC THROMBIN REAGENT (K970645) | Behring Diagnostics, Inc. | 1997-05-19 |
| BIOMERIEUX HEMOLAB THROMBICALCI-TEST (K925493) | Biomerieux Vitek, Inc. | 1994-04-21 |
| TEST THROMBIN (K930157) | Behring Diagnostics, Inc. | 1993-05-14 |
| THROMBIN CLOT TIME TEST PROCEDURE (K923220) | Medical Laboratory Automation Systems, Inc. | 1992-09-29 |
| TT AND HNTT BY HEMOCHRON (K900126) | International Technidyne Corp. | 1990-02-05 |
| THROMBIN TIME REAGENT (K894467) | Sigma Chemical Co. | 1989-09-05 |
| FIBRI-PREST/THROMBIN-PREST CONTROLS (K884385) | American Bioproducts Co. | 1988-12-28 |
| THROMBIN-PREST REAGENT KIT (K884384) | American Bioproducts Co. | 1988-12-28 |
| IL SYSTEM 810, ACL AND THE REAGENT SETS (K862301) | Instrumentation Laboratory CO | 1986-09-03 |
| THROMBINEX BOVINE THROMBIN (K845000) | Bio/Data Corp. | 1985-03-26 |
Recalls involving this device
No recalls on record reference this clearance.