Thrombin Clot Time Test Procedure
FDA 510(k) K923220 · Medical Laboratory Automation Systems, Inc.
510(k) numberK923220
Submission
- Device name
- Thrombin Clot Time Test Procedure
- Applicant
- Medical Laboratory Automation Systems, Inc.
Pleasantville, NY, US - Received
- July 1, 1992
- Decision date
- September 29, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GJA – Test, Thrombin Time
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7875
- Specialty
- Hematology
Other 510(k)s with product code GJA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050817 | T-TekGJA · Traditional | R2 Diagnostics, Inc. | 12/12/2005SE |
| K982209 | Accuclot Thrombin Time Reagent Model A8713/A4589GJA · Traditional | Sigma Diagnostics, Inc. | 10/15/1998SE |
| K970645 | BC Thrombin ReagentGJA · Traditional | Behring Diagnostics, Inc. | 05/19/1997SE |
| K925493 | Biomerieux Hemolab Thrombicalci-TestGJA · Traditional | Biomerieux Vitek, Inc. | 04/21/1994SE |
| K930157 | Test ThrombinGJA · Traditional | Behring Diagnostics, Inc. | 05/14/1993SE |
| K920147 | Thrombin Clotting Time ReagentGJA · Traditional | Helena Laboratories | 05/01/1992SE |
| K900126 | TT and HNTT by HemochronGJA · Traditional | International Technidyne Corp. | 02/05/1990SE |
| K894467 | Thrombin Time ReagentGJA · Traditional | Sigma Chemical Co. | 09/05/1989SE |
| K884385 | Fibri-Prest/Thrombin-Prest ControlsGJA · Traditional | American Bioproducts Co. | 12/28/1988SE |
| K884384 | Thrombin-Prest Reagent KitGJA · Traditional | American Bioproducts Co. | 12/28/1988SE |
More from American Bioproducts Co.
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|---|---|---|
| K962664 | Electra 1800C Automatic Coagulation AnalyzerGKP · Traditional | 09/10/1996SE |
| K944227 | Electra 1400C Automatic Coagulation AnalyzerGKP · Traditional | 02/03/1995SE |
| K931206 | Electra 1600C Automatic Coagulation TimerGKP · Traditional | 08/23/1993SE |
| K903638 | Gastro-Intestinal Accu-Culshure TMLIO · Traditional | 01/18/1991SE |
| K903406 | Viral Accu-Culshure TMLIO · Traditional | 10/16/1990SE |
| K903405 | Chlamydia Accu-Culshure TMLIO · Traditional | 10/16/1990SE |
| K901645 | Anaerobic Accu-Culshure(Tm)JTX · Traditional | 07/16/1990SE |
| K894052 | Electra 1000C Automatic Coagulation TimerGKP · Traditional | 07/27/1989SE |
| K884863 | Electra 900C Automatic Coagulation TimerGKP · Traditional | 02/03/1989SE |
| K871687 | Tytem(R) Reagent DispenserJQW · Traditional | 05/20/1987SE |
Questions and answers
When was Thrombin Clot Time Test Procedure cleared by the FDA?
Thrombin Clot Time Test Procedure (K923220) received a 510(k) decision of Substantially Equivalent on September 29, 1992, 90 days after the submission was received.
What is the product code of K923220?
The FDA product code is GJA – Test, Thrombin Time, a Class II (moderate risk) device regulated under 21 CFR 864.7875.