510(k) K895805
- Device
- SLIDEX ROTA-KIT 2
- Applicant
- VITEK SYSTEMS, INC.
- 510(k) number
- K895805
- Product code
- LIQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-02-26
- Date received
- 1989-09-28
- Regulation
- 866.3405
- Classification name
- Enzyme Linked Immunoabsorbent Assay, Rotavirus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID K BROADWAY
- Address
- 595 Anglum Dr. Hazelwood MI US 63042 63042
FDA Registration Numbers#
- 3003750284
- 3005360469
- 2030538
- 3003917514
- 2032839
- 2032682
- 3014150341
- 2182595
- 3024463179
- 2029372
- 3005984081
- 1524213
- 3022178699
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LIQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K990842 | SAS ROTA TEST | Sa Scientific, Inc. | 1999-08-09 |
| K972895 | VIDAS ROTAVIRUS (RTV) ASSAY | Biomerieux Vitek, Inc. | 1997-10-03 |
| K971585 | IMMUNOCARD STAT! ROTAVIRUS | Meridian Diagnostics, Inc. | 1997-08-20 |
| K964424 | ROTAVIRUS EIA | Trinity Biotech, Inc. | 1997-08-08 |
| K965092 | VIDAS ROTAVIRUS ASSAY | Biomerieux Vitek, Inc. | 1997-05-05 |
| K951208 | ROTA-DAN RAPID ROTAVIRUS EIA KIT | Eldan Technologies, Ltd. | 1996-02-14 |
| K942286 | DIARLEX ROTA-ADENO | Orion Diagnostica, Inc. | 1994-12-14 |
| K933587 | IMMUNOCARD ROTAVIRUS | Meridian Diagnostics, Inc. | 1994-02-03 |
| K932384 | IDEIA(TM) ROTAVIRUS | Dako Diagnostics , Ltd. | 1993-12-27 |
| K915137 | KALLESTAD ROTAVIRUS MICROPLATE | Bio-Rad Laboratories, Inc. | 1992-03-04 |
| K912666 | DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 | Dako Corp. | 1992-02-14 |
| K884017 | ROTACUBE | Difco Laboratories, Inc. | 1989-01-24 |
| K883940 | ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST | Ortho Diagnostic Systems, Inc. | 1989-01-04 |
| K883935 | ORTHO* ROTAVIRUS ANTIGEN ELISA TEST | Ortho Diagnostic Systems, Inc. | 1989-01-04 |
| K880821 | RESUBMITTED ABBOTT TESTPACK ROTAVIRUS | Abbott Laboratories | 1988-05-06 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases