Bblcrystal Anaerobe Id System
FDA 510(k) K944528 · Becton Dickinson Microbiology Systems
510(k) numberK944528
Submission
- Device name
- Bblcrystal Anaerobe Id System
- Applicant
- Becton Dickinson Microbiology Systems
Cockeysville, MD, US - Received
- September 15, 1994
- Decision date
- March 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K881380 | B. FragtexJSP · Traditional | American Biomedical Products, Inc. | 10/06/1988SE |
| 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 |
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| K984631 | Bdprobetec Et Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified DNA AssayLSL · Traditional | 11/04/1999SE |
| K981517 | Cefdinir, 5 Ug, Sensi-DiscJTN · Traditional | 06/09/1998SE |
| K980683 | Trovafloxacin 10G, Sensi-DiscJTN · Traditional | 05/01/1998SE |
| K974578 | Grepafloxacin, 5 MG, Sensi-DiscJTN · Traditional | 02/23/1998SE |
| K970333 | Bactec Myco/F Lytic Culture VialsMDB · Traditional | 01/28/1998SE |
| K970512 | Bactec Myco/F Lytic Culture VialsMDB · Traditional | 01/08/1998SE |
| K972758 | Bactec Myco/F-Sputa Culture VialsMDB · Traditional | 08/08/1997SE |
| K972098 | Fosfomycin, 200 MG, Sensi-DiscJTN · Traditional | 07/28/1997SE |
| K970385 | Sparflozacin, 5 MCG, Sensi-DiscJTN · Traditional | 03/10/1997SE |
Questions and answers
When was Bblcrystal Anaerobe Id System cleared by the FDA?
Bblcrystal Anaerobe Id System (K944528) received a 510(k) decision of Substantially Equivalent on March 7, 1995, 173 days after the submission was received.
What is the product code of K944528?
The FDA product code is JSP – Kit, Anaerobic Identification, a Class I (low risk) device regulated under 21 CFR 866.2660.