B. Fragtex
FDA 510(k) K881380 · American Biomedical Products, Inc.
510(k) numberK881380
Submission
- Device name
- B. Fragtex
- Applicant
- American Biomedical Products, Inc.
Tulsa, OK, US - Received
- April 1, 1988
- Decision date
- October 6, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSP – Kit, Anaerobic Identification
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JSP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945489 | Lyfo(Tm) Differential DiskJSP · Traditional | Microbiologics, Inc. | 05/11/1995SE |
| K945488 | Lyfo(Tm) Differential DiskJSP · Traditional | Microbiologics, Inc. | 05/11/1995SE |
| K945487 | Lyfo(Tm) Differential DiskJSP · Traditional | Microbiologics, Inc. | 05/11/1995SE |
| K944528 | Bblcrystal Anaerobe Id SystemJSP · Traditional | Becton Dickinson Microbiology Systems | 03/07/1995SE |
| K910666 | Vitek Anaerobe Identification Card, ModificationJSP · Traditional | Vitek Systems, Inc. | 04/03/1991SE |
| K900996 | Vitek Anaerobe Identification CardJSP · Traditional | Vitek Systems, Inc. | 05/11/1990SE |
| K882960 | Ids Rapid Ana SystemJSP · Traditional | Innovative Diagnostic Systems, Inc. | 08/12/1988SE |
| K855235 | Diagnostic Reagent Pet-RplaJSP · Traditional | Oxoid U.S.A., Inc. | 11/04/1986SE |
| K862332 | Anaerobe Rapid Chromogenic Id PanelJSP · Traditional | American Micro Scan | 08/27/1986SE |
| K850052 | Anaerobe KitJSP · Traditional | Austin Biological Laboratories | 03/05/1985SE |
Questions and answers
When was B. Fragtex cleared by the FDA?
B. Fragtex (K881380) received a 510(k) decision of Substantially Equivalent on October 6, 1988, 188 days after the submission was received.
What is the product code of K881380?
The FDA product code is JSP – Kit, Anaerobic Identification, a Class I (low risk) device regulated under 21 CFR 866.2660.