510(k) K811098
- Device
- SERO-STAT STAPHYLOCOCCUS TEST
- Applicant
- SCOTT LABORATORIES, INC.
- 510(k) number
- K811098
- Product code
- JWX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-05-05
- Date received
- 1981-04-22
- Regulation
- 866.2660
- Classification name
- Kit, Screening, Staphylococcus Aureus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9615755
- 1641328
- 2029372
- 8010096
- 3009307598
- 9615754
- 1924669
- 3003750284
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JWX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K090964 | BINAXNOX STAPHYLOCOCCUS AUREUS TEST | Binax, Inc. | 2009-12-16 |
| K972030 | STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS | Oxoid , Ltd. | 1997-09-08 |
| K964315 | REMEL STAPH LATEX KIT | Remel, L.P. | 1997-02-07 |
| K945538 | STAPHAUREX PLUS(TM) | Murex Diagnostics Limitd | 1995-06-01 |
| K926173 | STAPH-A-LEX(TM) SYSTEM | Trinity Laboratories, Inc. | 1993-08-10 |
| K923212 | SLIDEX STAPH-KIT | Biomerieux Vitek, Inc. | 1992-09-28 |
| K905617 | VISI-STAPH | Connecticut Diagnostics, Ltd. | 1991-03-29 |
| K902259 | AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT | Orthomet, Inc. | 1990-06-18 |
| K874019 | STAPHSLIDE | Ncs Diagnostics, Inc. | 1987-10-28 |
| K854278 | NEG COMBO BREAKPOINT PANEL POS COMBO | American Micro Scan | 1986-03-04 |
| K855220 | V-TREND KIT STAPH LATEX TEST | Texas Immunology, Inc. | 1986-03-03 |
| K852997 | RAPI - STAPH | Advanced Medical Technology, Inc. | 1985-08-19 |
| K843560 | BACTO STAPHYLOCOCCUS LATEX TEST | Difco Laboratories, Inc. | 1984-10-01 |
| K831918 | LA-STAPH IDENTIFICATION SYSTEM | Immuno-Mycologics, Inc. | 1983-06-08 |
| K830783 | VERI-STAPH | Zeus Technologies | 1983-04-08 |
Legacy Summary#
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FDA Review#
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