Gastro-Intestinal Accu-Culshure TM
FDA 510(k) K903638 · Medical Laboratory Automation Systems, Inc.
510(k) numberK903638
Submission
- Device name
- Gastro-Intestinal Accu-Culshure TM
- Applicant
- Medical Laboratory Automation Systems, Inc.
Pleasantville, NY, US - Received
- August 13, 1990
- Decision date
- January 18, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIO – Device, Specimen Collection
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2900
- Specialty
- Microbiology
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| K070062 | Coproset Salmonella and Shigella, Uriset Preservative Tubes and Swab Set General UseLIO · Traditional | Diesse Diagnostica Senese S.P.A. | 07/30/2007SE |
| K013711 | Bacti-Swab DryLIO · Traditional | Remel Co. | 11/26/2001SE |
| K003761 | Nat - Nucleic Acid TransportLIO · Traditional | Medical Packaging Corp. | 05/31/2001SE |
| K983119 | Entero-Test HP, Model #102-01LIO · Traditional | Hdc Corp. | 03/15/1999SE |
| K981391 | Par-OneLIO · Traditional | Remel, Inc. | 07/14/1998SE |
More from Remel, Inc.
| 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 |
| 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 Gastro-Intestinal Accu-Culshure TM cleared by the FDA?
Gastro-Intestinal Accu-Culshure TM (K903638) received a 510(k) decision of Substantially Equivalent on January 18, 1991, 158 days after the submission was received.
What is the product code of K903638?
The FDA product code is LIO – Device, Specimen Collection, a Class I (low risk) device regulated under 21 CFR 866.2900.