THROMBIN CLOT TIME TEST PROCEDURE
FDA 510(k) clearance K923220 · decided 1992-09-29
Clearance details
- K-number
- K923220
- Device name
- THROMBIN CLOT TIME TEST PROCEDURE
- Applicant
- Medical Laboratory Automation Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-07-01
- Decision date
- 1992-09-29
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- GJA
- Device class
- 2
- Regulation number
- 864.7875
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Pleasantville, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medical Laboratory Automation Systems
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.
| 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 CLOTTING TIME REAGENT (K920147) | Helena Laboratories | 1992-05-01 |
| 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.