510(k) K822466
- Device
- Thrombin Time Test
- Applicant
- AMERICAN DADE
- 510(k) number
- K822466
- Product code
- GJA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-09-14
- Date received
- 1982-08-16
- Regulation
- 864.7875
- Classification name
- Test, Thrombin Time
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2431530
- 3037000637
- 9610806
- 1835316
- 1618982
- 2245451
- 9710666
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GJA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050817 | T-TEK | R2 Diagnostics, Inc. | 2005-12-12 |
| K982209 | ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 | Sigma Diagnostics, Inc. | 1998-10-15 |
| K970645 | BC THROMBIN REAGENT | Behring Diagnostics, Inc. | 1997-05-19 |
| K925493 | BIOMERIEUX HEMOLAB THROMBICALCI-TEST | Biomerieux Vitek, Inc. | 1994-04-21 |
| K930157 | TEST THROMBIN | Behring Diagnostics, Inc. | 1993-05-14 |
| K923220 | THROMBIN CLOT TIME TEST PROCEDURE | Medical Laboratory Automation Systems, Inc. | 1992-09-29 |
| K920147 | THROMBIN CLOTTING TIME REAGENT | Helena Laboratories | 1992-05-01 |
| K900126 | TT AND HNTT BY HEMOCHRON | International Technidyne Corp. | 1990-02-05 |
| K894467 | THROMBIN TIME REAGENT | Sigma Chemical Co. | 1989-09-05 |
| K884384 | THROMBIN-PREST REAGENT KIT | American Bioproducts Co. | 1988-12-28 |
| K884385 | FIBRI-PREST/THROMBIN-PREST CONTROLS | American Bioproducts Co. | 1988-12-28 |
| K862301 | IL SYSTEM 810, ACL AND THE REAGENT SETS | Instrumentation Laboratory CO | 1986-09-03 |
| K845000 | THROMBINEX BOVINE THROMBIN | Bio/Data Corp. | 1985-03-26 |
| K841956 | BOVINE THROMBIN, HUMAN THROMBIN | Haemachem, Inc. | 1984-07-19 |
| K834301 | THROMBOLYTIC ACTIVITY TEST | Bio/Data Corp. | 1984-02-04 |