510(k) K874303
- Device
- STAPHYLASE TEST
- Applicant
- OXOID U.S.A., INC.
- 510(k) number
- K874303
- Product code
- LHT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-11-06
- Date received
- 1987-10-20
- Regulation
- 866.3700
- Classification name
- Staphylococcus Aureus Somatic Antigens
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RUTH KEMP
- Address
- 9017 Red Branch Rd. Columbia MD US 21045 21045
FDA Registration Numbers#
- 8010096
- 3003750284
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LHT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K863025 | SERO-STAT R II STAPHYLOCOCCUS TEST | Scott Laboratories, Inc. | 1986-09-15 |
| K820531 | ENDO-STAPH TEICHOIC ACID ANTIBODY KIT | Meridian Diagnostics, Inc. | 1982-04-14 |
| K820683 | STAPHYLOCOCCUS LATEX AGGLUTINATION KIT | American Scientific Products | 1982-04-14 |
| K820347 | ACCU-STAPH | Carr-Scarborough Microbiologicals, Inc. | 1982-03-04 |
| K812434 | DIAGNOSTIC KITS & KIT COMPONENTS | Diagnostica, Inc. | 1981-09-23 |
| K812367 | GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD) | Dutchland Laboratories, Inc. | 1981-09-09 |
| K812368 | RAT BLOOD IN ALSEVER'S, CITRATED | Dutchland Laboratories, Inc. | 1981-09-09 |
| K812372 | GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF | Dutchland Laboratories, Inc. | 1981-09-09 |
| K812373 | RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR | Dutchland Laboratories, Inc. | 1981-09-09 |
| K812374 | ADULT CHICKEN BLOOD IN ALSEVER'S, C., D. | Dutchland Laboratories, Inc. | 1981-09-09 |
| K812375 | BABY CHICK BLOOD IN ALSEVER'S | Dutchland Laboratories, Inc. | 1981-09-09 |
| K812376 | SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBR | Dutchland Laboratories, Inc. | 1981-09-09 |
Legacy Summary#
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FDA Review#
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