Anaerobic Accu-Culshure(Tm)
FDA 510(k) K901645 · Medical Laboratory Automation Systems, Inc.
510(k) numberK901645
Submission
- Device name
- Anaerobic Accu-Culshure(Tm)
- Applicant
- Medical Laboratory Automation Systems, Inc.
Pleasantville, NY, US - Received
- April 9, 1990
- Decision date
- July 16, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTX – Transport Systems, Anaerobic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2900
- Specialty
- Microbiology
Other 510(k)s with product code JTX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K897151 | Acuson V328 and C5432 TransducersJTX · Traditional | Acuson Corp. | 07/03/1990SE |
| K882637 | Accu-Culshure TMJTX · Traditional | Accu-Med Corp. | 07/06/1988SE |
| K791724 | Bio-Bag Environmental Chamber (a & B)JTX · Traditional | Marion Laboratories, Inc. | 10/17/1979SE |
| K781376 | Standardize TGCL & TGCHJTX · Traditional | American Monitor Corp. | 09/14/1978SE |
| K780159 | AnaswabJTX · Traditional | Scott Laboratories, Inc. | 02/13/1978SE |
| K761241 | Pre-Duced Surgi-Swab & Transporter TubeJTX · Traditional | Gibco Laboratories Life Technologies, Inc. | 12/30/1976SE |
| K760063 | Specimen Collector, AnaerobicJTX · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/03/1976SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K923220 | Thrombin Clot Time Test ProcedureGJA · Traditional | 09/29/1992SE |
| 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 |
| 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 Anaerobic Accu-Culshure(Tm) cleared by the FDA?
Anaerobic Accu-Culshure(Tm) (K901645) received a 510(k) decision of Substantially Equivalent on July 16, 1990, 98 days after the submission was received.
What is the product code of K901645?
The FDA product code is JTX – Transport Systems, Anaerobic, a Class I (low risk) device regulated under 21 CFR 866.2900.