510(k) K891004
- Device
- RAPIDEC STAPH
- Applicant
- DMS PRODUCTS, INC.
- 510(k) number
- K891004
- Product code
- LQL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-11-09
- Date received
- 1989-02-28
- Regulation
- 866.2660
- Classification name
- Gram Positive Identification Panel
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANIS FREESTONE
- Address
- Dart'S Mill Professional Vill. Rt. 523, Box 95 Flemington NJ US 08822 08822
FDA Registration Numbers#
- 3013718871
- 1950204
- 1119779
- 1924669
- 3009637528
- 8010096
- 3006440892
- 2919016
- 9615754
- 1530126
- 8021914
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LQL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972576 | GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 | Accumed Intl., Inc. | 1998-01-22 |
| K961730 | RAPID GRAM-POSITIVE ID SYSTEM | Becton Dickinson Microbiology Systems | 1997-02-04 |
| K961968 | BBLCRYSTAL GRAM-POSITIVE ID SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997-02-04 |
| K952095 | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) | Biomerieux Vitek, Inc. | 1996-03-12 |
| K925916 | VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD | Biomerieux Vitek, Inc. | 1993-03-23 |
| K910304 | RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA | Vitek Systems, Inc. | 1991-07-26 |
| K910537 | VISI-STREP | Kev Connecticut Diagnostics, Inc. | 1991-04-12 |
| K901559 | MODIFICATION TO API UNISCEPT 20GP | Analytical Products, Inc. | 1990-09-10 |
| K874606 | CATHRA GRAM POSITIVE SCREEN | Mct Medical, Inc. | 1988-05-06 |
| K863038 | GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL | American Micro Scan | 1986-09-30 |
Legacy Summary#
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FDA Review#
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