510(k) K911771
- Device
- Ard(tm) Antimicrobial Removal Device
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K911771
- Product code
- LJK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-07-01
- Date received
- 1991-04-19
- Regulation
- 866.3780
- Classification name
- Antisera, If, Toxoplasma Gondii
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- J ARNSBERGER
- Address
- 1 Becton Dr. Franklin Lakes NJ US 07417 07417
FDA Registration Numbers#
- 2032682
- 3007088335
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LJK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974261 | ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL | Boston Biomedica, Inc. | 1997-12-11 |
| K861122 | THE GOLDEN QUAD TEST (TOXO) | Microbiological Research Corp. | 1987-02-02 |
| K861460 | SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101 | Widran Urological Group, Ltd. | 1986-05-02 |
| K832069 | TOXO IPA KIT IAN INDIRECT FLUORESCENT | Bionetic Laboratory Products | 1983-09-26 |
| K822605 | TOXOPLASMA GONDII ANTIBODY IGG | Immulok, Inc. | 1982-10-27 |