510(k) K912897
- Device
- Sceptor Identification System
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K912897
- Product code
- LQM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-10-28
- Date received
- 1991-07-01
- Regulation
- 866.2660
- Classification name
- Gram Negative Identification Panel
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RUSSELL ARNSBERGER
- Address
- 1 Becton Dr. Franklin Lakes NJ US 07417 07417
FDA Registration Numbers#
- 3013718871
- 3035387168
- 1950204
- 1119779
- 1924669
- 3009637528
- 8010096
- 3006440892
- 2919016
- 1530126
- 8021914
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LQM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K923313 | ROCHE OXI/FERM II | Roche Diagnostic Systems, Inc. | 1993-04-05 |
| K925915 | VITEK RAPID CALL-GRAM NEGATIV IDENT CARD | Biomerieux Vitek, Inc. | 1993-03-23 |
| K911429 | VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED | Vitek Systems, Inc. | 1991-06-24 |
| K890057 | SENSITITRE AUTO ID PLATE AP80 | Radiometer America, Inc. | 1989-06-09 |
| K862642 | GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL | American Micro Scan | 1986-09-11 |
| K851528 | PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM | Pasco Laboratories, Inc. | 1985-07-15 |